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

November 26, 2010 updated by: Sanofi

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guatemala
      • Guatemala City, Guatemala
        • Sanofi-Aventis Administrative Office
  • Mexico
      • Col. Coyoacan, Mexico
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: at baseline, week 12 and week 24
at baseline, week 12 and week 24
Fasting and postprandial glucose
Time Frame: at baseline, week 2, 4, 12 and 24
at baseline, week 2, 4, 12 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Judith Diaz, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

August 11, 2009

First Submitted That Met QC Criteria

August 11, 2009

First Posted (Estimate)

August 12, 2009

Study Record Updates

Last Update Posted (Estimate)

November 30, 2010

Last Update Submitted That Met QC Criteria

November 26, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLIME_L_04140

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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