Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-Naive Patients - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00751114

Purpose

Primary objective:

To demonstrate the superiority of insulin glargine over sitagliptin in reducing HbA1c from baseline to the end of the treatment period.

Secondary objective:

To assess the effect of insulin glargine in comparison with sitagliptin on:

HbA1c level
Fasting Plasma Glucose
7-point plasma glucose profiles
Percentage of patients with HbA1c <7% and <6.5%
Safety parameters :
- Hypoglycemia occurrence
- Body weight
- Overall safety

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Insulin Glargine Drug: Sitagliptin	Phase IV

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Insulin Insulin glargine Metformin Metformin hydrochloride Sitagliptin phosphate Sitagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Superiority Study of Insulin Glargine Over Sitagliptin in Insulin-naïve Patients With Type 2 Diabetes Treated With Metformin and Not Adequately Controlled

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

HbA1c [ Time Frame: Recorded at baseline (week 0), visit 11 (week 12) and visit 14 (week 24) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma glucose profile [ Time Frame: Prior to baseline (week 0), visit 11 (week 12) and visit 14 (week 24) ] [ Designated as safety issue: No ]
Self-monitored FPG [ Time Frame: At baseline (week 0), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16) and visit 14 (week 24) ] [ Designated as safety issue: No ]
Weight [ Time Frame: At pre-screening visit (week -2), at baseline (week 0), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16) and visit 14 (week 24) ] [ Designated as safety issue: No ]
Insulin dose in the insulin glargine group [ Time Frame: At visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16) and visit 14 (week 24) ] [ Designated as safety issue: No ]
Hypoglycemia [ Time Frame: All across the study ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: All across the study ] [ Designated as safety issue: No ]
Vital signs [ Time Frame: All across the study ] [ Designated as safety issue: No ]
Laboratory data [ Time Frame: All across the study ] [ Designated as safety issue: No ]
Lipid profile [ Time Frame: At baseline (week 0), at visit 11 (week 12), and visit 14 (week 24) ] [ Designated as safety issue: No ]
7-point plasma glucose profile [ Time Frame: At baseline (week 0), at visit 11 (week 12), and visit 14 (week 24) ] [ Designated as safety issue: No ]

Estimated Enrollment:	530
Study Start Date:	October 2008
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Administered once a day, in the evening, at dinner or at bedtime	Drug: Insulin Glargine 100 Units/mL solution for injection in a pre-filled SoloStar® pen (3 mL)
2: Active Comparator Dose of 100 mg once a day, with or without food	Drug: Sitagliptin 100 mg film-coated tablets

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

With type 2 diabetes diagnosed for at least 6 months,
Not previously treated with insulin,
On metformin for at least 3 months and a stable minimal dose of 1 g/day for at least 2 months
HbA1c ≥ 7 and < 11 %,
BMI between 25 and 45 kg/m² inclusively,

Exclusion Criteria:

Treatment with oral antidiabetic drugs other than metformin within the last 3 months,
Previous treatment with the combination of metformin + sulfonylurea for more than 1 year,
Previous treatment with GLP-1 agonists or DPP IV inhibitors,
FPG (assessed by central laboratory measurement) ≥ 280 mg/dL (15.4 mmol/L),
Diabetes other than type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake...),
Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
In-patient care,
Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry),
Impaired renal function: serum creatinine ≥ 1.5 mg/dL (≥ 133µmol/L) or ≥ 1.4 mg/dL (≥ 124 µmol/L) in men and women, respectively,
History of sensitivity to the study drugs or to drugs with a similar chemical structure,
Impaired hepatic function (ALAT, ASAT > 3 x upper limit of normal range),
Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatment during the study that are not permitted during the study (exception: in case of chronic adrenal insufficiency, systemic glucosteroids are accepted only if the disease is stable and the treatment dose stable for at least 3 months before study entry),
Alcohol or drug abuse within the last year,
Night shift worker,
Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient's safety or limit the patient successful participation in the study,
Treatment with weight loss medications (e.g. sibutramine, orlistat, rimonabant) within the last 3 months,
Participation in another clinical trial within the month prior to visit 1.

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: NCT00751114

Contacts

Contact: Public Registry GMA Public Registry GMA

PublicRegistryGMA@sanofi-aventis.com

Show 18 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Diane Chalumeau, MD

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LANTU_C_02761, EudraCT # : 2008-000516-32
Study First Received:	September 10, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00751114
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin
Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009