Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00957060
• Date of registration: 11/08/2009
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients SUMER
• Scientific 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
• Date of first enrolment: July 2009
• Target sample size: 400
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00957060
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Guatemala, Mexico

Contacts

• Name: Judith Diaz
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: GLIMEPIRIDE (HOE490)

Drug: SITAGLIPTIN

Primary Outcome(s)

Fasting and postprandial glucose [Time Frame: at baseline, week 2, 4, 12 and 24]

HbA1c [Time Frame: at baseline, week 12 and week 24]

Secondary ID(s)

GLIME_L_04140

Source(s) of Monetary Support

Please refer to primary and secondary sponsors