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Completed

NCT Number: NCT01683266

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus

Primary Objective:

* To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus

Secondary Objective:

* To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of: * Change of HbA1c from baseline to endpoint (scheduled Month 6) * Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM) * Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia) * Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative) * Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number 124110, Coquitlam, Canada

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About this study

The maximum study duration was up to approximately 54 weeks per participants:

  • Up to 2-week screening period
  • 6-month open-label comparative efficacy and safety treatment period
  • 6-month open-label comparative safety extension period
  • 48-hour 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

  • Adult participants with type 1 diabetes mellitus

Exclusion criteria

  • HbA1c less than (<) 7.0% (53 mmol/mol) or greater than (>) 10% (86 mmol/mol) at screening
  • Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit
  • Participants not on stable insulin dose (+/-20 percent total basal insulin dose) in the last 30 days prior to screening visit
  • Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering 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 and no plan to switch to insulin pump in the next 12 months
  • Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening;
  • Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit
  • Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (example 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 (Insulin glargine new formulation)

Drug

Lantus (Insulin glargine)

Drug

Primary outcomes

  1. Change In HbA1c From Baseline to Month 6 Endpoint

    Time frame: Baseline, Month 6

Secondary outcomes

  1. Percentage of Participants With HbA1c <7% at Month 6 Endpoint

    Time frame: Month 6

  2. Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint

    Time frame: Month 6

  3. Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint

    Time frame: Baseline, Month 6

    Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.

  4. Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint

    Time frame: Baseline, Month 6

    Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.

  5. Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint

    Time frame: Baseline, Month 6

  6. Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6

    Time frame: Month 6

  7. Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint

    Time frame: Month 6

  8. Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint

    Time frame: Baseline, Month 6

    Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.

  9. Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint

    Time frame: Baseline, Month 6

  10. Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint

    Time frame: Baseline, Month 6

    DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.

  11. Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12

    Time frame: Up to Month 12

    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 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected in the Morning or Evening in Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period

Acronym: EDITION IV

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Sep 11, 2012
Registry last updated
Jun 24, 2015

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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