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Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients (SUMER)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00957060
First received: August 11, 2009
Last updated: November 26, 2010
Last verified: November 2010
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by Sanofi:

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 ]

Enrollment: 400
Study Start Date: July 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: glimepiride
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
Active Comparator: sitagliptin
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

Locations
Guatemala
Sanofi-Aventis Administrative Office
Guatemala City, Guatemala
Mexico
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Judith Diaz Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00957060     History of Changes
Other Study ID Numbers: GLIME_L_04140
Study First Received: August 11, 2009
Last Updated: November 26, 2010
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Sitagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013