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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


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
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