Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy (EDITION II)
This study is ongoing, but not recruiting participants.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01499095
First received: December 16, 2011
Last updated: June 11, 2013
Last verified: June 2013
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Purpose
Primary Objective:
- To compare the efficacy of insulin glargine new formulation and lantus in terms of Change in HbA1c from baseline to endpoint (scheduled month 6)
Secondary Objective:
- To compare the efficacy of insulin glargine new formulation and lantus in terms of occurrence of Hypoglycemia
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Lantus (Insulin glargine) Drug: Insulin glargine-new formulation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 Patients With Type 2 Diabetes Mellitus With a 6 Month Safety Extension Period |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Change in HbA1c [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurrence of hypoglycemia [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
- Fasting plasma glucose [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
- 8-point self-monitored plasma glucose profile [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
- Change in HbA1c (substudy) [ Time Frame: 6 months, 9 months ] [ Designated as safety issue: No ]
- Occurrence of Hypoglycemia (substudy - from month 6 to month 9) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 800 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | November 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Insulin glargine-new formulation
once daily on top of oral antidiabetic drugs
|
Drug: Insulin glargine-new formulation
Pharmaceutical form:solution Route of administration: subcutaneous |
|
Active Comparator: Lantus (insulin glargine)
once daily on top of oral antidiabetic drugs
|
Drug: Lantus (Insulin glargine)
Pharmaceutical form:solution Route of administration: subcutaneous Other Name: Lantus
|
Detailed Description:
The maximum study duration will be 58 weeks per patient, consisting of:
- up to 2 week screening period;
- 6-month comparative efficacy and safety treatment period;
- 6-month comparative safety extension period;
- 4-week safety follow-up period
- a 3-month administration substudy period starting after completion of the 6-month study period for patients willing to.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria :
o Patients with type 2 diabetes mellitus
Substudy inclusion criteria:
- Completion of the 6-month study period in main study (Visit 10)
- Randomized and treated with insulin glargine new formulation during the 6- month treatment period (Baseline - month 6)
Exclusion criteria:
- Age <18 years;
- HbA1c <7.0% or >10% at screening;
- Diabetes other than type 2 diabetes mellitus;
- Less than 6 months on basal insulin treatment together with oral antihyperglycemic drugs and self-monitoring of blood glucose;
- Patients using sulfonylurea in the last 2 months before screening visit;
- Any contraindication to use of insulin glargine as defined in the national product label;
- Use of insulin pump in the last 6 months before screening;
- Initiation of new glucose-lowering medications in the last 3 months before screening visit;
- History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period;
- Pregnant or breast-feeding women or women who intend to become pregnant during the study period
Substudy exclusion criteria:
o Patient not willing to use the adaptable injection intervals on at least two days per week
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499095
Show 233 Study Locations
Show 233 Study LocationsSponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01499095 History of Changes |
| Other Study ID Numbers: | EFC11629, 2010-023770-39, U1111-1118-6943 |
| Study First Received: | December 16, 2011 |
| Last Updated: | June 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glargine |
Insulin Hypoglycemic Agents Insulin, Long-Acting Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013