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Completed

NCT Number: NCT01658579

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

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

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number 840002, Temecula, California, United States

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About this study

  • Up to 4-week screening period;
  • 16-week open-label comparative efficacy and safety treatment period;
  • 4-week post-treatment safety follow-up period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HOE901-U300 (new formulation of insulin glargine)

Drug

Lantus (Insulin glargine)

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Change in HbA1c From Baseline to Week 8 and 16

    Time frame: Baseline, Week 8, 16

  6. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16

    Time frame: Baseline, Week 8, 16

  7. 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.

  8. Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16

    Time frame: Baseline, Week 8, 16

  9. 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).

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 7, 2012
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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