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

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ClinicalTrials.gov Identifier: NCT01658579
Recruitment Status : Completed
First Posted : August 7, 2012
Results First Posted : May 7, 2015
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE July 26, 2012
First Posted Date  ICMJE August 7, 2012
Results First Submitted Date  ICMJE March 24, 2015
Results First Posted Date  ICMJE May 7, 2015
Last Update Posted Date June 1, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2015)
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) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2012)
Percent (%) of time in target plasma glucose range [ Time Frame: up to 16 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • 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) ]
    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) ]
    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) ]
    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.
  • 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 ]
    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 ]
  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16 [ Time Frame: Baseline, Week 8, 16 ]
  • Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16 [ Time Frame: Baseline, Week 8, 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.
  • Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16 [ Time Frame: Baseline, Week 8, 16 ]
  • Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16 [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2012)
  • Change in HbA1c [ Time Frame: from baseline to 16 weeks ]
  • Change in FPG [ Time Frame: from baseline to 16 weeks ]
  • Change in 7-point self-monitored plasma glucose [ Time Frame: from baseline to 16 weeks ]
  • Hypoglycemia [ Time Frame: Up to 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin
Official Title  ICMJE 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
Brief 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
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Drug: HOE901-U300 (new formulation of insulin glargine)
  • Drug: Lantus (insulin glargine)
Study Arms  ICMJE
  • 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)
Publications * Bergenstal RM, Bailey TS, Rodbard D, Ziemen M, Guo H, Muehlen-Bartmer I, Ahmann AJ. Comparison of Insulin Glargine 300 Units/mL and 100 Units/mL in Adults With Type 1 Diabetes: Continuous Glucose Monitoring Profiles and Variability Using Morning or Evening Injections. Diabetes Care. 2017 Apr;40(4):554-560. doi: 10.2337/dc16-0684. Epub 2017 Jan 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2015)
59
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2012)
56
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01658579
Other Study ID Numbers  ICMJE PDY12777
U1111-1130-3593 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date May 2015

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