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OpenTrials
Completed

NCT Number: NCT01459809

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number 01206, Algeries, Algeria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glimepiride

Drug

Pharmaceutical form: oral

Route of administration: oral

Other names: HOE490

metformin

Drug

Pharmaceutical form: oral

Route of administration: oral

Primary outcomes

  1. Change in HbA1c

    Time frame: from baseline to week 24

Secondary outcomes

  1. Percentage of patients with HbA1c < 7%

    Time frame: at week 24

  2. Percentage of patients with HbA1c < 6.5 %

    Time frame: at week 24

  3. Change in Fasting Plasma Glucose (FPG)

    Time frame: from baseline week 24

  4. Number of patients reporting adverse events

    Time frame: overt the 24-weeks treatment period

  5. Frequence and incidence of hypoglycemia

    Time frame: over the 24-weeks treatment period

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: RECOMMEND

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 26, 2011
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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