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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
GLIMEPIRIDE (HOE490)
SITAGLIPTIN
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

glimepiride

sitagliptin

Arm Description

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.

100 mg once a day. The dose will not be titrated.

Outcomes

Primary Outcome Measures

HbA1c
Fasting and postprandial glucose

Secondary Outcome Measures

Full Information

First Posted
August 11, 2009
Last Updated
November 26, 2010
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00957060
Brief Title
Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients
Acronym
SUMER
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
glimepiride
Arm Type
Experimental
Arm Description
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.
Arm Title
sitagliptin
Arm Type
Active Comparator
Arm Description
100 mg once a day. The dose will not be titrated.
Intervention Type
Drug
Intervention Name(s)
GLIMEPIRIDE (HOE490)
Intervention Description
Pharmaceutical form: 2 mg and 4 mg tablets Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
SITAGLIPTIN
Intervention Description
Pharmaceutical form: 100 mg tablets Route of administration: oral
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
at baseline, week 12 and week 24
Title
Fasting and postprandial glucose
Time Frame
at baseline, week 2, 4, 12 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Diaz
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Guatemala City
Country
Guatemala
Facility Name
Sanofi-Aventis Administrative Office
City
Col. Coyoacan
Country
Mexico

12. IPD Sharing Statement

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Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients

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