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CompletedNCT00708578Updated Jan 25, 2011

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

A Phase 4 interventional study of Glimepiride and Metformin in Type 2 Diabetes Mellitus, sponsored by Sanofi. Completed at 1 site in South Korea. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-01-25.

Sponsored by Sanofi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 99 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
99 participants (actual)

Study arms

  • Active comparator
    1

    Administration of 4 mg of Glimepiride with Insulin Glargine

    Drug: Glimepiride · Drug: Insulin Glargine

  • Active comparator
    2

    Administration of 1500 mg of Metformin with Insulin Glargine

    Drug: Metformin · Drug: Insulin Glargine

  • Experimental
    3

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

    Drug: Glimepiride · Drug: Metformin · Drug: Insulin Glargine

Interventions

06

What researchers measure

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

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Seoul, South Korea
08

References and documents

Publications

  • 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. PubMed 24614911 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00708578
Lead sponsor
Sanofi
First posted
Jul 2, 2008
Start date
May 2008
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Jan 25, 2011

Study contacts

Ji Young Ahn
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Metformin

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