Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: HOE901-U300 (new formulation of insulin glargine)
Drug: Lantus (Insulin glargine)

Registration Number: NCT01499095

Lead Sponsor: Sanofi

Brief Summary: Primary Objective:

* To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus

Secondary Objective:

* 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 participants, 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: 811

Inclusion Criteria

Not provided

Exclusion Criteria

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	Only measurements performed before initiation of rescue therapy were considered in the analysis.

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 mmol/L (70 milligram per deciliter \[mg/dL\]). Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint	Baseline, Month 6	Preinjection 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. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint	Baseline, Month 6	Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of co-efficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Percentage of Participants With HbA1c <7% at Month 6 Endpoint	Month 6	Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint	Baseline, Month 6	Only measurements performed before initiation of rescue therapy were considered in the analysis.
Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint	Month 6	Only measurements performed before initiation of rescue therapy were considered in the analysis.
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. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint	Baseline, Month 6	Only measurements performed before initiation of rescue therapy were considered in the analysis.
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. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline 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 (213): Investigational Site Number 840517
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Birmingham, Alabama, United States
Investigational Site Number 840149
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Chandler, Arizona, United States
Investigational Site Number 840093
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Glendale, Arizona, United States
Investigational Site Number 840069
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Phoenix, Arizona, United States
Investigational Site Number 840110
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Sun City, Arizona, United States
Investigational Site Number 840068
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Tempe, Arizona, United States
Investigational Site Number 840015
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Hot Springs, Arkansas, United States
Investigational Site Number 840014
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Little Rock, Arkansas, United States
Investigational Site Number 840114
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Little Rock, Arkansas, United States
Investigational Site Number 840018
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Mountain Home, Arkansas, United States
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Investigational Site Number 840517
🇺🇸Birmingham, Alabama, United States