Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00957060

Purpose

Primary Objective:

To determine the superiority of glimepiride over sitagliptin in the reduction of HbA1c after 6 months of treatment in patients with monotherapy until the end of the trial.

Secondary Objective:

To evaluate the effect of glimepiride compared to sitagliptin in:

Glucose in fasting conditions; Postprandial glucose; Percentage of patients with HbA1c < 7% and < 6.5%; Symptomatic Hypoglycemia; Body weight; Percentage of withdrawal and percentage of patients with rescue therapy; Safety (adverse events and serious adverse events, hypoglycemia, vital signs and laboratory results).

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: GLIMEPIRIDE (HOE490) Drug: SITAGLIPTIN	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open, Randomized, 24 Weeks Study to Evaluate the Superiority of Glimepiride Over Sitagliptin for the Treatment of naïve Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glimepiride Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

HbA1c [ Time Frame: at baseline, week 12 and week 24 ] [ Designated as safety issue: No ]
Fasting and postprandial glucose [ Time Frame: at baseline, week 2, 4, 12 and 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	394
Study Start Date:	July 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
glimepiride: Experimental The initial dose is 2 mg once a day. At week 2, the dose can be increased to 4 mg once a day according to the titration. At week 4 and 12, the dose can be increased from 2 mg to 4 mg or from 4 mg to 6 mg according to the titration.	Drug: GLIMEPIRIDE (HOE490) Pharmaceutical form: 2 mg and 4 mg tablets Route of administration: oral
sitagliptin: Active Comparator 100 mg once a day. The dose will not be titrated.	Drug: SITAGLIPTIN Pharmaceutical form: 100 mg tablets Route of administration: oral

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Subject naïve to treatment
HbA1c > 8.5 up to 11 %
Lipid lowering therapy, antihypertensive, hormonal substitutes, thyroid hormone substitutes, and contraceptives are allowed as long as they are kept at a stable dosing

Exclusion criteria:

Treatment with any oral antidiabetics or insulin
Known type 1 Diabetes Mellitus
Pregnant or breast feeding women
Ketoacidosis history
History of sensitivity to any of the active substances
Renal dysfunction : serum creatinine > or = 1.5 mg/dL in male subjects > or = 1.4 mg/dL in female subjects
Liver impairment (ALT, AST > 3-fold the upper limit of normal range)
Systemic corticosteroid treatment 3 months prior to study or during the study
Drug or alcohol abuse history
Patients with history of acute coronary syndrome, cerebrovascular events/transient ischaemic attack in the last three months
Presence of any condition (medical, psychological, social or geographic) current or previously seen that according to Investigators judgment jeopardizes the safety or restricts the participation of the patient during the study
Neoplasias

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: NCT00957060

Contacts

Contact: Public Registry GMA

PublicRegistryGMA@sanofi-aventis.com

Locations

Guatemala
Sanofi-aventis Administrative Office	Recruiting
Guatemala City, Guatemala
Mexico
Sanofi-aventis Administrative Office	Recruiting
Col. Coyoacan, Mexico

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Judith Diaz

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	GLIME_L_04140
Study First Received:	August 11, 2009
Last Updated:	December 3, 2009
ClinicalTrials.gov Identifier:	NCT00957060 History of Changes
Health Authority:	Mexico: Ministry of Health

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Immunosuppressive Agents
Pharmacologic Actions

Protease Inhibitors
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010