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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

A 16-week, Randomized, Open-label, Controlled Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine Versus Lantus in Patients With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658579
• Other study ID #: PDY12777
• Secondary ID: U1111-1130-3593
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2012
• Last updated: May 7, 2015
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria :

• Participants with Type 1 diabetes mellitus

Exclusion criteria:

• HbA1c greater than (>) 9% (at screening)

• Participants receiving >0.5 U/kg body weight basal insulin in the last 30 days prior to screening visit

• Participants not on stable insulin dose (+/- 20% total basal insulin dose) in the last 30 days prior to screening visit

• Less than 1 year on any basal plus mealtime insulin

• Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any antidiabetic drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit

• Use of an insulin pump in the last 6 months before screening visit;

• Any contraindication to use of insulin glargine as defined in the national product label

• Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening

• Hospitalization for diabetic ketoacidosis or history of severe hypoglycemia (requiring 3rd party assistance) in the last 6 months prior to randomization

• Initiation of any glucose-lowering agents in the last 3 months before screening visit

• Weight change of greater than equal to (>=) 5 kg during the last 3 months prior to screening visit

• Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require laser, surgical treatment or injectable drugs during the study period

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• HOE901-U300 (new formulation of insulin glargine)

• Lantus (insulin glargine)

Locations

Country	Name	City	State
United States	Investigational Site Number 840001	Minneapolis	Minnesota
United States	Investigational Site Number 840003	Portland	Oregon
United States	Investigational Site Number 840002	Temecula	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])	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.	Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)	No
Secondary	Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])	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.	Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)	No
Secondary	Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])	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.	Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)	No
Secondary	Evaluation of Diurnal Glucose Exposure, Variability, and Stability	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.	Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)	No
Secondary	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	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.	Weeks 7-8 in Period A and Weeks 15-16 in Period B	No
Secondary	Change in HbA1c From Baseline to Week 8 and 16		Baseline, Week 8, 16	No
Secondary	Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16		Baseline, Week 8, 16	No
Secondary	Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 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.	Baseline, Week 8, 16	No
Secondary	Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16		Baseline, Week 8, 16	No
Secondary	Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline 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).	Up to Week 16	Yes