Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941… (NCT00767000) | Clinical Trial Compass
TerminatedPhase 2
Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)
813 participantsStarted 2008-10
Plain-language summary
The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c (HbA1c) level than will placebo added to insulin at 14 weeks, and that MK-0941 will be well-tolerated at 1 or more doses that demonstrate efficacy.
Who can participate
Age range
21 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* has type 2 diabetes mellitus
* has body mass index \>20 and \<43 kg/m\^2
* is a male, or a female who is unlikely to conceive
* currently on a stable dose of insulin with or without metformin for Type 2 diabetes mellitus
Extension Study Inclusion Criteria:
* completed the base study either on double-blind study medication or as part of the post-treatment follow up population
* had ≥85% compliance with double-blind and open-label medication during the base study double-blind treatment period
Exclusion Criteria:
* has any history of Type 1 diabetes mellitus or ketoacidosis
* has received more that 1 week of thiazolidinedione (such as pioglitazone or rosiglitazone) therapy or injectable increatin-based therapy (such as Byetta) within the prior 8 weeks
* has had ≥2 episodes during their lifetime or \>1 episode within the past year resulting in hypoglycemic seizures, comas, or unconsciousness
* is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of Visit 1
* has undergone surgery within 30 days prior to Visit 1 or has planned major surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Hemoglobin A1c (HbA1c) Level
Timeframe: Baseline and Weeks 14, 54, 106, and 158
2
Percentage of Participants Who Experienced at Least One Adverse Event
Timeframe: Entire study including 54-week study and 104-week extension
3
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event
Timeframe: Entire study including 54-week study and 104-week extension