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

NCT00708578 | Completed Phase 4

• 1 other identifier: LANTU_L_02670
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c values

  At baseline to end of treatment

Secondary Outcomes (3)

• Hypoglycemia events

  From inclusion to end of study

• Percentage of patients with HbA1c < 7%

  At the end of the study

• Fasting Blood Glucose level

  At the end of the study

Study Arms (3)

1

ACTIVE COMPARATOR

Administration of 4 mg of Glimepiride with Insulin Glargine

Drug: Glimepiride; Drug: Insulin Glargine

2

ACTIVE COMPARATOR

Administration of 1500 mg of Metformin with Insulin Glargine

Drug: Metformin; Drug: Insulin Glargine

3

EXPERIMENTAL

Administration of a combination of 4mg Glimepiride plus 1000mg Metformin with Insulin Glargine

Drug: Glimepiride; Drug: Metformin; Drug: Insulin Glargine

Interventions

Glimepiride DRUG

Once a day before breakfast

1; 3

Metformin DRUG

After breakfast and supper

2; 3

Insulin Glargine DRUG

Injection in the morning

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \< HbA1c \< 11 %
• Fasting serum C-peptide \> 0.33 nmol/L
• BMI \< 30 kg/m²
• Patients who is willing to monitor BG using SMBG

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Seoul, South Korea

Location

Related Publications (1)

• Park CY, Kang JG, Chon S, Noh J, Oh SJ, Lee CB, Park SW. Comparison between the therapeutic effect of metformin, glimepiride and their combination as an add-on treatment to insulin glargine in uncontrolled patients with type 2 diabetes. PLoS One. 2014 Mar 10;9(3):e87799. doi: 10.1371/journal.pone.0087799. eCollection 2014.

  PMID: 24614911 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepiride; Metformin; Insulin Glargine

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; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ji Young Ahn

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 2, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 25, 2011

Record last verified: 2011-01

Locations

KR (1)