Comparison of a New Formulation of Insulin Glargine With Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus (EDITION JP II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01689142
First received: September 14, 2012
Last updated: December 23, 2013
Last verified: December 2013

September 14, 2012
December 23, 2013
September 2012
November 2013   (final data collection date for primary outcome measure)
Change from baseline in HbA1c [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
Change in HbA1c [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01689142 on ClinicalTrials.gov Archive Site
  • Percentage of HbA1c responders (HbA1c < 7%; < 6.5%) [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in FPG [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in pre-basal insulin injection SMPG [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in 8-point SMPG profiles [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values) [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in variability of plasma glucose profile [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in daily basal insulin dose [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Number of patients with various types of hypoglycemia events [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Change in pre-injection plasma glucose [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in 8-point self-monitored plasma glucose profile [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of a New Formulation of Insulin Glargine With Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus
A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus With a 6 Month Safety Extension Period

Primary Objective:

To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese patients with type 2 diabetes mellitus.

Secondary Objectives:

To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose (SMPG) profile.

To compare a new formulation of insulin glargine and Lantus in terms of occurrence of hypoglycemia

The duration of study will consist of:

  • Up to 2-week screening period;
  • 6-month open-label comparative efficacy and safety treatment period;
  • 6-month open-label comparative safety extension period;
  • 4-week post-treatment safety follow-up period
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Insulin glargine new formulation (HOE901)
    Pharmaceutical form: solution Route of administration: subcutaneous
  • Drug: Insulin glargine (HOE901)
    Pharmaceutical form: solution Route of administration: subcutaneous
    Other Name: Lantus
  • Experimental: New formulation of insulin glargine
    once daily in the evening on-top of oral antihyperglycemic drug (OADs)
    Intervention: Drug: Insulin glargine new formulation (HOE901)
  • Active Comparator: Lantus (insulin glargine)
    once daily in the evening on-top of OADs
    Intervention: Drug: Insulin glargine (HOE901)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
June 2014
November 2013   (final data collection date for primary outcome measure)

Inclusion criteria :

o Patients with type 2 diabetes mellitus diagnosed for at least 1 year at the time of screening visit treated with basal insulin in combination with oral antihyperglycemic drugs (OADs) for at least 6 months before screening visit;

Exclusion criteria:

  • Age < 18 years at screening visit;
  • BMI(body mass index) ≥ 35 kg/m2 at screening visit;
  • HbA1c < 7.0% or > 10% (national glycohemoglobin standardization program [NGSP] value) at screening visit;
  • Diabetes other than type 2 diabetes mellitus;
  • Patients on self-monitoring of blood glucose less than 6 months before screening visit;
  • Patients using pre-mix insulins, insulin detemir at 2 times or more a day, or GLP 1 receptor agonists in the last 3 months before screening visit;
  • Patients using mealtime insulin (rapid-acting insulin analogue and short-acting insulin) for more than 10 days in the last 3 months before screening visit;
  • Use of insulin pump in the last 6 months before screening visit;
  • Initiation of new glucose-lowering medications and/or weight loss drugs in the last 3 months before screening visit;
  • 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 (eg, laser, surgical treatment or injectable drugs) during the study period.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01689142
EFC12512, U1111-1130-3649
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
December 2013

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