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OpenTrials
Completed

NCT Number: NCT00708578

Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin)

Primary objective:

To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level

Secondary objective:

To compare the incidence of hypoglycemia in each treatment group

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes for at least 6 months
  • Treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea (glimepiride≥ 4 mg/day or equivalent dose of other SU) for at least 3 months prior to the screening visit
  • 7.0 < HbA1c < 11 %
  • Fasting serum C-peptide > 0.33 nmol/L
  • BMI < 30 kg/m²
  • Patients who is willing to monitor BG using SMBG

Exclusion criteria

  • Type 1 Diabetes
  • Clinical evidence of active liver disease, or serum ALT 3 times the upper limit of the normal range
  • Serum creatinine: ≥ 1.5 mg/dl for males, ≥ 1.4 mg/dl for females
  • Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
  • History of alcohol or other substance abuse
  • Pregnancy or not using contraceptive in childbearing aged women
  • Breast feeding women
  • History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
  • Treatment with any medication including corticosteroid or herbal medicines that can affect blood glucose level within 3 months prior to study entry except metformin and sulfonylurea.

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

Once a day before breakfast

metformin

Drug

After breakfast and supper

insulin glargine

Drug

Injection in the morning

Primary outcomes

  1. HbA1c values

    Time frame: At baseline to end of treatment

Secondary outcomes

  1. Hypoglycemia events

    Time frame: From inclusion to end of study

  2. Percentage of patients with HbA1c < 7%

    Time frame: At the end of the study

  3. Fasting Blood Glucose level

    Time frame: At the end of the study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Insulin Glargine Combined With Sulfonylurea Versus Metformin in Patients With Type 2 Diabetes: A Randomized, Controlled Trial.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 2, 2008
Registry last updated
Jan 25, 2011

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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