Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy - Full Text View

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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Hypoglycemia

Drug Information available for: Insulin human Insulin glargine

U.S. FDA Resources

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:	October 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

Sponsors 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:	May 17, 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 May 23, 2013

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)