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

NCT01459809 | Completed Phase 3 DMC

• 2 other identifiers: GLIME_R_05809U1111-1119-9984
• Study Type: interventional
• Target: 538
• Locations: 13 countries
• Sites: 48

Brief 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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  from baseline to week 24

Secondary Outcomes (5)

• Percentage of patients with HbA1c < 7%

  at week 24

• Percentage of patients with HbA1c < 6.5 %

  at week 24

• Change in Fasting Plasma Glucose (FPG)

  from baseline week 24

• Number of patients reporting adverse events

  overt the 24-weeks treatment period

• Frequence and incidence of hypoglycemia

  over the 24-weeks treatment period

Study Arms (3)

ARM 1: glimepiride alone

EXPERIMENTAL

24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if Fasting Plasma Glucose (FPG) at baseline \< 180 mg/dL (10 mmol/L) taken once in the morning before breakfast. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg, and adjusted throughout the 24-week treatment period according to fasting Self Monitored Plasma Glucose (SMPG) values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and \> 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia.

Drug: GLIMEPIRIDE

ARM 2: metformin alone

EXPERIMENTAL

24-week treatment period: After randomization, starting dose will be of 500 mg of metformin twice a day during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 2000 mg, and adjusted throughout the 24-week treatment period according to fasting SMPG values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and \> 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia.

Drug: METFORMIN

ARM3: Glimepiride/metformin free combination

EXPERIMENTAL

24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if FPG at baseline \< 180 mg/dL (10 mmol/L) taken once in the morning and 500 mg of metformin twice a day taken during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg of glimepiride and 2000 mg of metformin, and adjusted throughout the 24-week treatment period according to fasting SMPG values in the objective to obtain values ≤.

Drug: GLIMEPIRIDE; Drug: METFORMIN

Interventions

GLIMEPIRIDE DRUG

Pharmaceutical form: oral Route of administration: oral

Also known as: HOE490

ARM 1: glimepiride alone; ARM3: Glimepiride/metformin free combination

METFORMIN DRUG

Pharmaceutical form: oral Route of administration: oral

ARM 2: metformin alone; ARM3: Glimepiride/metformin free combination

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (55)

Investigational Site Number 01206

Algeries, Algeria

Location

Investigational Site Number 01203

Oran, 31000, Algeria

Location

Investigational Site Number 01205

Sétif, 19000, Algeria

Location

Investigational Site Number 17003

El Espinal, Colombia

Location

Investigational Site Number 170001

Manizales, 170, Colombia

Location

Investigational Site Number 81801

Cairo, Egypt

Location

Investigational Site Number 81802

Cairo, Egypt

Location

Investigational Site Number 81803

Cairo, Egypt

Location

Investigational Site Number 32001

Guatemala City, Guatemala

Location

Investigational Site Number 32002

Guatemala City, Guatemala

Location

Investigational Site Number 32003

Guatemala City, Guatemala

Location

Investigational Site Number 32004

Guatemala City, Guatemala

Location

Investigational Site Number 356001

Bangalore, 560043, India

Location

Investigational Site Number 356002

Bangalore, 560052, India

Location

Investigational Site Number 356006

Ernākulam, India

Location

Investigational Site Number 356003

Indore, 452010, India

Location

Investigational Site Number 356009

Lucknow, 226003, India

Location

Investigational Site Number 356010

Mumbai, India

Location

Investigational Site Number 356007

Nashik, 422002, India

Location

Investigational Site Number 356008

Pune, 411007, India

Location

Investigational Site Number 356005

Varanasi, India

Location

Investigational Site Number 364001

Tehran, 1411413137, Iran

Location

Investigational Site Number 364002

Tehran, 1666694516, Iran

Location

Investigational Site Number 36403

Tehran, Iran

Location

Investigational Site Number 42201

Beirut, Lebanon

Location

Investigational Site Number 42202

Beirut, Lebanon

Location

Investigational Site Number 42203

Chouf, Lebanon

Location

Investigational Site Number 422004

Hazmiyeh, Lebanon

Location

Investigational Site Number 484002

Guadalajara, 44340, Mexico

Location

Investigational Site Number 484003

Guadalajara, 44670, Mexico

Location

Investigational Site Number 643003

Moscow, 119002, Russia

Location

Investigational Site Number 643001

Saint Petersburg, Russia

Location

Investigational Site Number 643002

Saratov, 410012, Russia

Location

Investigational Site Number 710-002

Durban, 4091, South Africa

Location

Investigational Site Number 710-001

Durban, 4092, South Africa

Location

Investigational Site Number 78803

La Marsa, 2070, Tunisia

Location

Investigational Site Number 78804

La Marsa, 2070, Tunisia

Location

Investigational Site Number 78805

Sfax, Tunisia

Location

Investigational Site Number 78801

Tunis, Tunisia

Location

Investigational Site Number 78802

Tunis, Tunisia

Location

Investigational Site Number 78806

Tunis, Tunisia

Location

Investigational Site Number 78807

Tunis, Tunisia

Location

Investigational Site Number 792-004

Adana, Turkey (Türkiye)

Location

Investigational Site Number 792-003

Antalya, 07070, Turkey (Türkiye)

Location

Investigational Site Number 792-001

Istanbul, 34722, Turkey (Türkiye)

Location

Investigational Site Number 792-006

Istanbul, 34890, Turkey (Türkiye)

Location

Investigational Site Number 792-002

Kütahya, Turkey (Türkiye)

Location

Investigational Site Number 792-005

Sivas, 58140, Turkey (Türkiye)

Location

Investigational Site Number 804001

Kyiv, 02175, Ukraine

Location

Investigational Site Number 804002

Kyiv, 04114, Ukraine

Location

Investigational Site Number 804003

Zaporizhzhya, Ukraine

Location

Investigational Site Number 784-001

Dubai, United Arab Emirates

Location

Investigational Site Number 784-002

Dubai, United Arab Emirates

Location

Investigational Site Number 784-003

Dubai, United Arab Emirates

Location

Investigational Site Number 784-004

Sharjah city, 46458, United Arab Emirates

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepiride; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 26, 2011
• Study Start: February 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

IN (9); ME (2); RU (3); TU (6); UA (3); ZA (2); AE (4); LE (4); IR (3); EG (3); GU (4); AL (3); CO (2)