A Phase IIa, Multicenter, Double-Blind, Randomized, Active-Controlled, Parallel-Arm Clinical Trial to Study the Efficacy and Safety of MK-0941 Compared to Sulfonylurea in Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Metformin Therapy - MK-0941 Compared to Glimepiride as Add-on Therapy to Metformin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005616-40-SE

Enrollment

168

Registered

2008-12-09

Start date

2009-02-03

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Interventions

Product Name: MK-0941 Pharmaceutical Form: Tablet Current Sponsor code: MK-0941 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the place

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient has type 2 diabetes mellitus (T2DM). Patient is =18 and =70 years of age on day of signing informed consent. Patient has a body mass index (BMI) >20 kg/m2 and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis, or patient is assessed by the investigator as possibly having type 1 diabetes confirmed with a C peptide 5 years without documentation of remission/cure. Patient is being treated with the following glaucoma medications (or anticipated to be treated with during the study): ecothiophate, pilocarpine, or carbachol. Patient is allergic to ophthalmologic dilation medications (i.e., cyclophenylate, phenylephrine). Patient has had, or is anticipated to have, intraocular surgery (incisional surgery) within the past 6 months Patient has had ocular herpes, uveitis, or iritis within the past 3 months Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the past year) of drug or increase

Design outcomes

Primary

Measure	Time frame
Main Objective: After 6 weeks of treatment, to assess the effect of the addition of MK 0941 compared with the addition of glimepiride on 24-hour weighted mean glucose (24-hour WMG).;Primary end point(s): 24-hour weighted mean glucose;Secondary Objective: Exploratory objectives : (1) After 6 weeks of treatment, to assess the effect of the addition of MK 0941 on 2-hour post-meal glucose (PMG) and fasting plasma glucose (FPG) (2) After 6 weeks of treatment, to assess the rate of hypoglycemia with the addition of MK-0941. (3) After 6 weeks of treatment, to assess the effect of the addition of MK 0941 on body weight.	—

Measure

Time frame

Main Objective: After 6 weeks of treatment, to assess the effect of the addition of MK 0941 compared with the addition of glimepiride on 24-hour weighted mean glucose (24-hour WMG).;Primary end point(s): 24-hour weighted mean glucose;Secondary Objective: Exploratory objectives : (1) After 6 weeks of treatment, to assess the effect of the addition of MK 0941 on 2-hour post-meal glucose (PMG) and fasting plasma glucose (FPG) (2) After 6 weeks of treatment, to assess the rate of hypoglycemia with the addition of MK-0941. (3) After 6 weeks of treatment, to assess the effect of the addition of MK 0941 on body weight.

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Countries

Estonia, Finland, Ireland, Italy, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026