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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00957060
Recruitment Status : Completed
First Posted : August 12, 2009
Last Update Posted : November 30, 2010
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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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: GLIMEPIRIDE (HOE490) Drug: SITAGLIPTIN Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

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.
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.
Pharmaceutical form: 100 mg tablets Route of administration: oral

Primary Outcome Measures :
  1. HbA1c [ Time Frame: at baseline, week 12 and week 24 ]
  2. Fasting and postprandial glucose [ Time Frame: at baseline, week 2, 4, 12 and 24 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00957060

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Sanofi-Aventis Administrative Office
Guatemala City, Guatemala
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Sponsors and Collaborators
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Study Director: Judith Diaz Sanofi
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Responsible Party: Trial Transparency Team, sanofi-aventis Identifier: NCT00957060    
Other Study ID Numbers: GLIME_L_04140
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: November 30, 2010
Last Verified: November 2010
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors