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Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: GLIMEPIRIDE (Drug); METFORMIN (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

Summary

Primary Objective:

- To demonstrate the superiority of glimepiride and metformin free combination in comparison

to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus. Secondary Objectives:

- To assess the effects of the free combination of glimepiride and metformin in comparison

to glimepiride or metformin alone on:

- Percentage of patients reaching HbA1c < 7%

- Percentage of patients reaching HbA1c < 6. 5%

- Fasting Plasma Glucose (FPG)

- Safety and tolerability

Clinical Details

Official title: A Multinational, Open Label, Randomized, Active-controlled, 3-arm Parallel Group, 24-week Study Comparing the Combination of Glimepiride and Metformin Versus Glimepiride and Metformin Alone in Patients With Type 2 Diabetes

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in HbA1c

Secondary outcome:

Percentage of patients with HbA1c < 7%

Percentage of patients with HbA1c < 6.5 %

Change in Fasting Plasma Glucose (FPG)

Number of patients reporting adverse events

Frequence and incidence of hypoglycemia

Detailed description: The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period where patient is assigned to one of the three arms according to randomization, and 3 days follow-up period with a last call phone visit.

Eligibility

Minimum age: 18 Years. Maximum age: 78 Years. Gender(s): Both.

Criteria:

Inclusion criteria

- Patients with type 2 diabetes mellitus, as defined by the World Health Organization

(WHO), diagnosed within one year prior to the screening visit

- Signed informed consent, obtained prior to any study procedure

Exclusion criteria

- Age < 18 and => 78 years old

- HbA1c < 7. 6% or > 9%

- BMI > 35 kg/m2

- Diabetes other than type 2 diabetes (e. g.: type 1 diabetes, diabetes secondary to

pancreatic disorders, drug or chemical agent intake...)

- Subjects currently receiving or who have received any hypoglycemic agent within 3

months before screening visit The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations and Contacts

Investigational Site Number 01206, Algeries, Algeria

Investigational Site Number 01203, Oran 31000, Algeria

Investigational Site Number 01205, Setif 19000, Algeria

Investigational Site Number 17003, El Espinal, Colombia

Investigational Site Number 170001, Manizales 170, Colombia

Investigational Site Number 81801, Cairo, Egypt

Investigational Site Number 81802, Cairo, Egypt

Investigational Site Number 81803, Cairo, Egypt

Investigational Site Number 32001, Guatemala, Guatemala

Investigational Site Number 32002, Guatemala, Guatemala

Investigational Site Number 32003, Guatemala, Guatemala

Investigational Site Number 32004, Guatemala, Guatemala

Investigational Site Number 356001, Bangalore 560043, India

Investigational Site Number 356002, Bangalore 560052, India

Investigational Site Number 356006, Ernakulam, India

Investigational Site Number 356003, Indore 452010, India

Investigational Site Number 356009, Lucknow 226003, India

Investigational Site Number 356010, Mumbai, India

Investigational Site Number 356007, Nashik 422002, India

Investigational Site Number 356008, Pune 411007, India

Investigational Site Number 356005, Varanasi, India

Investigational Site Number 364001, Tehran 1411413137, Iran, Islamic Republic of

Investigational Site Number 364002, Tehran 1666694516, Iran, Islamic Republic of

Investigational Site Number 36403, Tehran, Iran, Islamic Republic of

Investigational Site Number 42201, Beirut, Lebanon

Investigational Site Number 42202, Beirut, Lebanon

Investigational Site Number 42203, Chouf, Lebanon

Investigational Site Number 422004, Hazmieh, Lebanon

Investigational Site Number 484002, Guadalajara 44340, Mexico

Investigational Site Number 484003, Guadalajara 44670, Mexico

Investigational Site Number 643003, Moscow 119002, Russian Federation

Investigational Site Number 643002, Saratov 410012, Russian Federation

Investigational Site Number 643001, St.-Petersburg, Russian Federation

Investigational Site Number 710-001, Durban 4092, South Africa

Investigational Site Number 710-002, Durban 4091, South Africa

Investigational Site Number 78803, La Marsa 2070, Tunisia

Investigational Site Number 78804, La Marsa 2070, Tunisia

Investigational Site Number 78805, Sfax, Tunisia

Investigational Site Number 78801, Tunis, Tunisia

Investigational Site Number 78802, Tunis, Tunisia

Investigational Site Number 78806, Tunis, Tunisia

Investigational Site Number 78807, Tunis, Tunisia

Investigational Site Number 792-004, Adana, Turkey

Investigational Site Number 792-003, Antalya 07070, Turkey

Investigational Site Number 792-001, Istanbul 34722, Turkey

Investigational Site Number 792-006, Istanbul 34890, Turkey

Investigational Site Number 792-002, Kutahya, Turkey

Investigational Site Number 792-005, Sivas 58140, Turkey

Investigational Site Number 804001, Kyiv 02175, Ukraine

Investigational Site Number 804002, Kyiv 04114, Ukraine

Investigational Site Number 804003, Zaporozhye, Ukraine

Investigational Site Number 784-001, Dubai, United Arab Emirates

Investigational Site Number 784-002, Dubai, United Arab Emirates

Investigational Site Number 784-003, Dubai, United Arab Emirates

Investigational Site Number 784-004, Sharjah 46458, United Arab Emirates

Additional Information

Starting date: February 2012
Last updated: January 19, 2015

Page last updated: August 20, 2015

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