Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin

Phase 2

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: Lantus (insulin glargine); Drug: HOE901-U300 (new formulation of insulin glargine)

• Registration Number: NCT01658579
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

* To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus

Secondary Objectives:

* To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening

* To compare the incidence and frequency of hypoglycemic episodes

* To assess the safety and tolerability of the new formulation of insulin glargine

Detailed Description

* Up to 4-week screening period;

* 16-week open-label comparative efficacy and safety treatment period;

* 4-week post-treatment safety follow-up period.

Study Timeline

• Study First Submitted: 2012-07-26
• Study Start: 2012-08
• Study First Submitted QC: 2012-08-02
• Study First Posted: 2012-08-07
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Disposition First Submitted: 2014-04-08
• Disposition First Submitted QC: 2014-04-08
• Disposition First Posted: 2014-05-02
• Results First Submitted: 2015-03-24
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-05
• Results First Posted: 2015-05-07
• Last Update Submitted: 2015-05-07
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lantus Evening Then Morning	Lantus (insulin glargine)	Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.
HOE901-U300 Morning Then Evening	HOE901-U300 (new formulation of insulin glargine)	HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 millimole per liter (mmol/L).
HOE901-U300 Evening Then Morning	HOE901-U300 (new formulation of insulin glargine)	HOE901-U300 (new insulin glargine 300 U/mL) SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.
Lantus Morning Then Evening	Lantus (insulin glargine)	Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.

Primary Outcome Measures

Name	Time	Method
Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])	Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)	Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.

Secondary Outcome Measures

Name	Time	Method
Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])	Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)	Percentage of time with glucose above the upper limit of glycemic range (\>7.8 mmol/L) was assessed by the total time above the upper limit of glycemic range divided by the length of the assessment interval.
Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])	Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)	Percentage of time with glucose below the lower limit of glycemic range (\<4.4 mmol/L) was assessed by the total time below the lower limit of glycemic range divided by the length of the assessment interval.
Evaluation of Diurnal Glucose Exposure, Variability, and Stability	Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)	The diurnal glucose exposure is measured as the average diurnal glucose concentration, diurnal glucose variability is measured by interquartile range (IQR), that is, average distance between the 25th and the 75th point-wise percentiles and diurnal glucose stability is assessed in terms of the mean absolute rate of change (mmol/l), that is, the area under the absolute rate of change of the median curve (based on the median point values between two adjacent hourly basket intervals), divided by the length of the assessment interval.
Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) in the Last Four Hours of Each Dosing Interval at Weeks 7 and 8 in Period A and Weeks 15 and 16 in Period B	Weeks 7-8 in Period A and Weeks 15-16 in Period B	Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.
Change in HbA1c From Baseline to Week 8 and 16	Baseline, Week 8, 16
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16	Baseline, Week 8, 16
Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16	Baseline, Week 8, 16	Change in average of 7-point SMPG. 7-point SMPG was assessed starting with a measurement at before breakfast and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; at bedtime.
Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16	Baseline, Week 8, 16
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16	Up to Week 16	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 (3)

Investigational Site Number 840002; 🇺🇸 Temecula, California, United States

Investigational Site Number 840003; 🇺🇸 Portland, Oregon, United States

Investigational Site Number 840001; 🇺🇸 Minneapolis, Minnesota, United States