Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Insulin Glargine (HOE901 - U300)
Drug: Insulin Glargine (HOE901 - U100)
Drug: Background therapy

Registration Number: NCT02320721

Lead Sponsor: Sanofi

Brief Summary: Primary Objective:

To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c).

Secondary Objectives:

To demonstrate the superiority of H0E901-U300 in comparison with Lantus in:

* Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event from 22:00 to 08:59 next morning

* Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL \[3.9mmol/L\]) hypoglycemia event

* Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event occurring at any time of day

* HbA1c change

Detailed Description: The study consisted of a 4-week screening period, a 26-week treatment period comparing HOE901-U300 to Lantus, and a 2-day safety follow-up period.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1014

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HOE901-U300	Insulin Glargine (HOE901 - U300)	HOE901-U300 (Insulin glargine, 300 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
HOE901-U300	Background therapy	HOE901-U300 (Insulin glargine, 300 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Lantus	Insulin Glargine (HOE901 - U100)	Lantus (Insulin glargine, 100 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Lantus	Background therapy	Lantus (Insulin glargine, 100 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c From Baseline to Week 26	Baseline, Week 26	Adjusted least square (LS) means were obtained from analysis of covariance (ANCOVA) after multiple imputation of missing data including post baseline HbA1c data during the 26-week randomized period.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (22:00 to 08:59 Hours Next Morning) During 26-Week Randomized Period	Baseline up to Week 26	Estimated percentages from multiple imputation approach including data from the 26-week randomized period. 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 ≤3.9 mmol/L (70 mg/dL).
Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (00:00 to 05:59 Hours) During 26-Week Randomized Period	Baseline up to Week 26	Estimated percentages from multiple imputation approach including data from the 26-week randomized period. 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 ≤3.9 mmol/L (70 mg/dL).
Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia Occurring at Any Time of the Day During 26-Week Randomized Period	Baseline up to Week 26	Estimated percentages from multiple imputation approach including data from the 26-week randomized period. 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 ≤3.9 mmol/L (70 mg/dL).
Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26	Baseline, Week 26	WHO-5 well-being index evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions, each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score was transformed into a percentage score ranging from 0 (worst possible quality of life) to 100 (best possible quality of life).
Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment	Baseline up to Week 26	Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after Week 14) values were used to determine the requirement of rescue medication. Threshold values at Week 14: FPG \>200 mg/dL (11 mmol/L), or HbA1c \>8.5%.
Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period	Baseline up to Week 26	Participants without any available HbA1c assessment at Week 26 were considered as non-responders in the analyses.
Percentage of Participants With HbA1c <7.5% or <7.0% at Week 26 and No Severe and/or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia During 26-Week Randomized Period	Baseline up to Week 26	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 ≤3.9 mmol/L (70 mg/dL).
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26	Baseline, Week 26	Adjusted LS means from multiple imputation approach including post baseline values during the 26-week randomized period.

Trial Locations

Locations (162): Investigational Site Number 840058
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Saraland, Alabama, United States
Investigational Site Number 840019
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Fresno, California, United States
Investigational Site Number 840021
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Fresno, California, United States
Investigational Site Number 840040
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Greenbrae, California, United States
Investigational Site Number 840070
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Huntington Park, California, United States
Investigational Site Number 840064
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Los Angeles, California, United States
Investigational Site Number 840031
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Norwalk, California, United States
Investigational Site Number 840065
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Oakland, California, United States
Investigational Site Number 840050
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Orange, California, United States
Investigational Site Number 840036
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Simi Valley, California, United States
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Investigational Site Number 840058
🇺🇸Saraland, Alabama, United States