Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: HOE901-U300 (new formulation of insulin glargine)
- Registration Number
- NCT01499082
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
* To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus
Secondary Objectives:
* To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia
- Detailed Description
The maximum study duration was up to approximately 58 weeks per participant, consisting of:
* up to 2 week screening period
* 6-month comparative efficacy and safety treatment period
* 6-month comparative safety extension period
* 4-week safety follow-up period in a subset of participants
* a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 807
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HOE901-U300 HOE901-U300 (new formulation of insulin glargine) - Lantus Lantus (insulin glargine) -
- Primary Outcome Measures
Name Time Method Change in HbA1c From Baseline to Month 6 Endpoint Baseline, Month 6
- Secondary Outcome Measures
Name Time Method Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint Week 9 Up to Month 6 Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (\<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter \[mg/dL\]).
Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint Baseline, Month 6 Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.
Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint Baseline, Month 6 Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.
Percentage of Participants With HbA1c <7% at Month 6 Endpoint Month 6 Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint Baseline, Month 6 Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint Month 6 Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint Baseline, Month 6 Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.
Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint Baseline, Month 6 Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint Baseline, Month 6 DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Up to Month 12 Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of \<=3.9 mmol/L \[70 mg/dL\]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level \<=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level \<=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level \>3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose \<=3.9 mmol/L).
Trial Locations
- Locations (193)
Investigational Site Number 840036
🇺🇸Baltimore, Maryland, United States
Investigational Site Number 840001
🇺🇸Dallas, Texas, United States
Investigational Site Number 840155
🇺🇸Baltimore, Maryland, United States
Investigational Site Number 840082
🇺🇸Houston, Texas, United States
Investigational Site Number 528006
🇳🇱Utrecht, Netherlands
Investigational Site Number 528002
🇳🇱Venlo, Netherlands
Investigational Site Number 840085
🇺🇸Minneapolis, Minnesota, United States
Investigational Site Number 840058
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 840008
🇺🇸Cincinnati, Ohio, United States
Investigational Site Number 840079
🇺🇸Greer, South Carolina, United States
Investigational Site Number 840066
🇺🇸Dearborn, Michigan, United States
Investigational Site Number 840042
🇺🇸Paducah, Kentucky, United States
Investigational Site Number 840126
🇺🇸Kalamazoo, Michigan, United States
Investigational Site Number 840143
🇺🇸Chaska, Minnesota, United States
Investigational Site Number 840043
🇺🇸Brick, New Jersey, United States
Investigational Site Number 840116
🇺🇸Des Moines, Iowa, United States
Investigational Site Number 840103
🇺🇸Flint, Michigan, United States
Investigational Site Number 840122
🇺🇸Mentor, Ohio, United States
Investigational Site Number 840080
🇺🇸Lexington, Kentucky, United States
Investigational Site Number 840022
🇺🇸Southfield, Michigan, United States
Investigational Site Number 840112
🇺🇸Norfolk, Virginia, United States
Investigational Site Number 840100
🇺🇸Avon, Indiana, United States
Investigational Site Number 840127
🇺🇸Vincennes, Indiana, United States
Investigational Site Number 840034
🇺🇸Rockville, Maryland, United States
Investigational Site Number 840152
🇺🇸Toms River, New Jersey, United States
Investigational Site Number 124015
🇨🇦Montreal, Canada
Investigational Site Number 233002
🇪🇪Pärnu, Estonia
Investigational Site Number 203001
🇨🇿Breclav, Czechia
Investigational Site Number 840074
🇺🇸Norfolk, Virginia, United States
Investigational Site Number 203003
🇨🇿Hradec Kralove, Czechia
Investigational Site Number 840039
🇺🇸Chattanooga, Tennessee, United States
Investigational Site Number 840035
🇺🇸Chesapeake, Virginia, United States
Investigational Site Number 840145
🇺🇸Hickory, North Carolina, United States
Investigational Site Number 840159
🇺🇸Knoxville, Tennessee, United States
Investigational Site Number 124024
🇨🇦Beamsville, Canada
Investigational Site Number 840060
🇺🇸Ogden, Utah, United States
Investigational Site Number 840075
🇺🇸Williamsburg, Virginia, United States
Investigational Site Number 124006
🇨🇦Laval, Canada
Investigational Site Number 840007
🇺🇸Uniontown, Pennsylvania, United States
Investigational Site Number 840048
🇺🇸Rapid City, South Dakota, United States
Investigational Site Number 840120
🇺🇸Hurst, Texas, United States
Investigational Site Number 840041
🇺🇸Norfolk, Virginia, United States
Investigational Site Number 233001
🇪🇪Tallinn, Estonia
Investigational Site Number 203008
🇨🇿Praha 2, Czechia
Investigational Site Number 233003
🇪🇪Tallinn, Estonia
Investigational Site Number 203005
🇨🇿Prostejov, Czechia
Investigational Site Number 203007
🇨🇿Hranice, Czechia
Investigational Site Number 233006
🇪🇪Tallinn, Estonia
Investigational Site Number 348011
🇭🇺Sátorlaljaújhely, Hungary
Investigational Site Number 528009
🇳🇱Almelo, Netherlands
Investigational Site Number 528004
🇳🇱Eindhoven, Netherlands
Investigational Site Number 840003
🇺🇸Wichita, Kansas, United States
Investigational Site Number 840071
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 840084
🇺🇸Portland, Oregon, United States
Investigational Site Number 124023
🇨🇦Calgary, Canada
Investigational Site Number 124019
🇨🇦Chatham, Canada
Investigational Site Number 124025
🇨🇦Burlington, Canada
Investigational Site Number 124018
🇨🇦Coquitlam, Canada
Investigational Site Number 124021
🇨🇦Hamilton, Canada
Investigational Site Number 124004
🇨🇦Montreal, Canada
Investigational Site Number 124008
🇨🇦Mississauga, Canada
Investigational Site Number 124009
🇨🇦London, Canada
Investigational Site Number 124002
🇨🇦Red Deer, Canada
Investigational Site Number 124007
🇨🇦Thornhill, Canada
Investigational Site Number 124011
🇨🇦Toronto, Canada
Investigational Site Number 124017
🇨🇦Ville St-Laurent, Canada
Investigational Site Number 124022
🇨🇦Winnipeg, Canada
Investigational Site Number 348010
🇭🇺Baja, Hungary
Investigational Site Number 348008
🇭🇺Eger, Hungary
Investigational Site Number 348018
🇭🇺Gyula, Hungary
Investigational Site Number 428002
🇱🇻Riga, Latvia
Investigational Site Number 428006
🇱🇻Jekabpils, Latvia
Investigational Site Number 348002
🇭🇺Budapest, Hungary
Investigational Site Number 348017
🇭🇺Budapest, Hungary
Investigational Site Number 233004
🇪🇪Tallinn, Estonia
Investigational Site Number 233005
🇪🇪Tartu, Estonia
Investigational Site Number 246001
🇫🇮Helsinki, Finland
Investigational Site Number 246002
🇫🇮Oulu, Finland
Investigational Site Number 348014
🇭🇺Makó, Hungary
Investigational Site Number 484007
🇲🇽Chihuahua, Mexico
Investigational Site Number 246005
🇫🇮Kuopio, Finland
Investigational Site Number 348013
🇭🇺Budapest, Hungary
Investigational Site Number 348009
🇭🇺Budapest, Hungary
Investigational Site Number 348003
🇭🇺Szeged, Hungary
Investigational Site Number 484004
🇲🇽Pachuca, Mexico
Investigational Site Number 642008
🇷🇴Iasi, Romania
Investigational Site Number 642007
🇷🇴Timisoara, Romania
Investigational Site Number 642006
🇷🇴Bucuresti, Romania
Investigational Site Number 642009
🇷🇴Targu Mures, Romania
Investigational Site Number 840067
🇺🇸Fargo, North Dakota, United States
Investigational Site Number 840068
🇺🇸Eagan, Minnesota, United States
Investigational Site Number 840070
🇺🇸Tempe, Arizona, United States
Investigational Site Number 124020
🇨🇦Calgary, Canada
Investigational Site Number 840156
🇺🇸Chandler, Arizona, United States
Investigational Site Number 840102
🇺🇸Glendale, Arizona, United States
Investigational Site Number 840121
🇺🇸Sun City, Arizona, United States
Investigational Site Number 840015
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 840016
🇺🇸Hot Springs, Arkansas, United States
Investigational Site Number 840076
🇺🇸Anaheim, California, United States
Investigational Site Number 840032
🇺🇸Searcy, Arkansas, United States
Investigational Site Number 840124
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 840133
🇺🇸Encino, California, United States
Investigational Site Number 840057
🇺🇸Huntington Beach, California, United States
Investigational Site Number 840062
🇺🇸Greenbrae, California, United States
Investigational Site Number 840059
🇺🇸La Jolla, California, United States
Investigational Site Number 840107
🇺🇸Palm Springs, California, United States
Investigational Site Number 840004
🇺🇸La Mesa, California, United States
Investigational Site Number 840099
🇺🇸Mission Hills, California, United States
Investigational Site Number 840013
🇺🇸Tustin, California, United States
Investigational Site Number 840114
🇺🇸Colorado Springs, Colorado, United States
Investigational Site Number 840002
🇺🇸Walnut Creek, California, United States
Investigational Site Number 840005
🇺🇸San Diego, California, United States
Investigational Site Number 840136
🇺🇸Colorado Springs, Colorado, United States
Investigational Site Number 840092
🇺🇸Longmont, Colorado, United States
Investigational Site Number 840049
🇺🇸Daytona Beach, Florida, United States
Investigational Site Number 840009
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840086
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840050
🇺🇸Hollywood, Florida, United States
Investigational Site Number 840011
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840148
🇺🇸Palm Harbor, Florida, United States
Investigational Site Number 840012
🇺🇸Ocoee, Florida, United States
Investigational Site Number 840055
🇺🇸Lawrenceville, Georgia, United States
Investigational Site Number 840023
🇺🇸New Port Richey, Florida, United States
Investigational Site Number 840020
🇺🇸McHenry, Illinois, United States
Investigational Site Number 840019
🇺🇸Springfield, Illinois, United States
Investigational Site Number 840097
🇺🇸Avon, Indiana, United States
Investigational Site Number 840078
🇺🇸Avon, Indiana, United States
Investigational Site Number 840089
🇺🇸Avon, Indiana, United States
Investigational Site Number 840098
🇺🇸Avon, Indiana, United States
Investigational Site Number 840106
🇺🇸Columbus, Ohio, United States
Investigational Site Number 840119
🇺🇸Maumee, Ohio, United States
Investigational Site Number 840083
🇺🇸Medford, Oregon, United States
Investigational Site Number 840123
🇺🇸Dayton, Ohio, United States
Investigational Site Number 840047
🇺🇸Dallas, Texas, United States
Investigational Site Number 124005
🇨🇦Oshawa, Canada
Investigational Site Number 124014
🇨🇦Hamilton, Canada
Investigational Site Number 124001
🇨🇦Toronto, Canada
Investigational Site Number 124010
🇨🇦Victoria, Canada
Investigational Site Number 124026
🇨🇦Quebec, Canada
Investigational Site Number 203006
🇨🇿Beroun, Czechia
Investigational Site Number 203009
🇨🇿Holesov, Czechia
Investigational Site Number 203002
🇨🇿Hodonin, Czechia
Investigational Site Number 203004
🇨🇿Krnov, Czechia
Investigational Site Number 203010
🇨🇿Olomouc, Czechia
Investigational Site Number 250004
🇫🇷La Rochelle Cedex, France
Investigational Site Number 276006
🇩🇪Heidelberg, Germany
Investigational Site Number 276003
🇩🇪Schwabenheim, Germany
Investigational Site Number 276002
🇩🇪Riesa, Germany
Investigational Site Number 250002
🇫🇷Strasbourg, France
Investigational Site Number 348004
🇭🇺Balatonfüred, Hungary
Investigational Site Number 348015
🇭🇺Budapest, Hungary
Investigational Site Number 348005
🇭🇺Debrecen, Hungary
Investigational Site Number 348012
🇭🇺Mosonmagyaróvár, Hungary
Investigational Site Number 348007
🇭🇺Nyiregyháza, Hungary
Investigational Site Number 348006
🇭🇺Szombathely, Hungary
Investigational Site Number 348001
🇭🇺Zalaegerszeg, Hungary
Investigational Site Number 428005
🇱🇻Ogre, Latvia
Investigational Site Number 428001
🇱🇻Riga, Latvia
Investigational Site Number 428003
🇱🇻Sigulda, Latvia
Investigational Site Number 428004
🇱🇻Riga, Latvia
Investigational Site Number 484001
🇲🇽Cuernavaca, Mexico
Investigational Site Number 484006
🇲🇽Guadalajara, Mexico
Investigational Site Number 484003
🇲🇽Monterrey, Mexico
Investigational Site Number 528005
🇳🇱Hoogeveen, Netherlands
Investigational Site Number 528007
🇳🇱Groningen, Netherlands
Investigational Site Number 528001
🇳🇱Hoorn, Netherlands
Investigational Site Number 642001
🇷🇴Bacau, Romania
Investigational Site Number 528008
🇳🇱Leeuwarden, Netherlands
Investigational Site Number 642005
🇷🇴Bucuresti, Romania
Investigational Site Number 642002
🇷🇴Cluj Napoca, Romania
Investigational Site Number 710003
🇿🇦Johannesburg, South Africa
Investigational Site Number 642004
🇷🇴Iasi, Romania
Investigational Site Number 642003
🇷🇴Oradea, Romania
Investigational Site Number 710005
🇿🇦Alberton, South Africa
Investigational Site Number 710006
🇿🇦Lenasia, South Africa
Investigational Site Number 710002
🇿🇦Observatory, South Africa
Investigational Site Number 710008
🇿🇦Pretoria, South Africa
Investigational Site Number 710001
🇿🇦Paarl, South Africa
Investigational Site Number 710004
🇿🇦Somerset West, South Africa
Investigational Site Number 840090
🇺🇸Fremont, Nebraska, United States
Investigational Site Number 840045
🇺🇸Wilmington, North Carolina, United States
Investigational Site Number 840010
🇺🇸Draper, Utah, United States
Investigational Site Number 840052
🇺🇸Idaho Falls, Idaho, United States
Investigational Site Number 840053
🇺🇸Kalispell, Montana, United States
Investigational Site Number 840117
🇺🇸Nampa, Idaho, United States
Investigational Site Number 840146
🇺🇸Asheville, North Carolina, United States
Investigational Site Number 840065
🇺🇸Ann Arbor, Michigan, United States
Investigational Site Number 840091
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 840018
🇺🇸Milwaukee, Wisconsin, United States
Investigational Site Number 840021
🇺🇸Austin, Texas, United States
Investigational Site Number 840129
🇺🇸Austin, Texas, United States
Investigational Site Number 840081
🇺🇸Austin, Texas, United States
Investigational Site Number 840104
🇺🇸Richmond, Virginia, United States