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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01658579
First received: July 26, 2012
Last updated: May 5, 2015
Last verified: May 2015

July 26, 2012
May 5, 2015
August 2012
May 2013   (final data collection date for primary outcome measure)
Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) [ Time Frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B) ] [ Designated as safety issue: No ]
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.
Percent (%) of time in target plasma glucose range [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01658579 on ClinicalTrials.gov Archive Site
  • Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL]) [ Time Frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B) ] [ Designated as safety issue: No ]
    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]) [ Time Frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B) ] [ Designated as safety issue: No ]
    The diurnal glucose exposure is measured as the average diurnal glucose concentration, diurnal glucose variability is measured by interquartile range (IQR), 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 [ Time Frame: Weeks 7-8 in Period A and Weeks 15-16 in Period B ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 8, 16 ] [ Designated as safety issue: No ]
  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16 [ Time Frame: Baseline, Week 8, 16 ] [ Designated as safety issue: No ]
  • Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16 [ Time Frame: Baseline, Week 8, 16 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 8, 16 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16 [ Time Frame: Up to Week 16 ] [ Designated as safety issue: Yes ]
    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).
  • Change in HbA1c [ Time Frame: from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Change in FPG [ Time Frame: from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Change in 7-point self-monitored plasma glucose [ Time Frame: from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Hypoglycemia [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin
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

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
  • Up to 4-week screening period;
  • 16-week open-label comparative efficacy and safety treatment period;
  • 4-week post-treatment safety follow-up period.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
  • Drug: HOE901-U300 (new formulation of insulin glargine)
  • Drug: Lantus (insulin glargine)
  • Experimental: HOE901-U300 Morning Then Evening
    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).
    Intervention: Drug: HOE901-U300 (new formulation of insulin glargine)
  • Experimental: HOE901-U300 Evening Then Morning
    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.
    Intervention: Drug: HOE901-U300 (new formulation of insulin glargine)
  • Active Comparator: Lantus Morning Then Evening
    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.
    Intervention: Drug: Lantus (insulin glargine)
  • Active Comparator: Lantus Evening Then Morning
    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.
    Intervention: Drug: Lantus (insulin glargine)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
May 2013
May 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01658579
PDY12777, U1111-1130-3593
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP