A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of MK-0941 in Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Insuli

Phase 1

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

• Registration Number: EUCTR2008-006215-20-FR
• Lead Sponsor: aboratoires MSD-Chibret

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-12
• Study Completion: 2010-05-26
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 87

Inclusion Criteria

1. Patient is between 21 and 70 years of age.
2. Patient has type 2 diabetes mellitus and meets one of the following criteria:
•On a stable dose of Lantus insulin monotherapy >=15 units/day for at least 6 weeks and has a Visit 1/Screening Visit A1C of =7.5% and ?11.0%
•On any injectable insulin (other than Lantus) at a stable dose of >=15 units/day, either alone or in combination with an oral monotherapy agent for at least 6 weeks and has a Visit 1/Screening A1C of =7.0% and ?10.5%
•On any injectable insulin at a stable dose of >=15 units/day, in combination with two oral agents for at least 6 weeks and has a Visit 1/Screening A1C of =6.5% and <=10.0%
3. Patient is a male or a female who is highly unlikely to conceive (i.e., patient is a male, patient is not of reproductive potential, patient is of reproductive potential and agrees to remain abstinent or use 2 acceptable methods of birth control).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
2. Patient has received more than 1 week of dosing of TZD therapy or injectable incretin-base therapy within the past 8 weeks.
3. Patient has a history of severe hypoglycemia defined as 2 or more episodes during his/her lifetime or one episode within the past year that resulted in hypoglycemic seizures and/or cerebral impairment (e.g. coma, severe confusion, etc.) or patient has had hypoglycemia unawareness (i.e.,fingerstick glucose <50 mg/dL [2.8 mmol/L] without symptoms) within the past 3 months.
4. Patient has a contraindication to Lantus insulin.
5. Patient meets one of the following medication exclusions:
•Taking weight loss medication (e.g. orlistat, sibutramine, rimonabant, etc) within 8 weeks of Visit 1/Screening Visit.
•Currently taking or likely to require treatment with > 14 consecutive days or repeated courses of pharmacological doses of systemic (oral, injectable/parenteral) or ocular corticosteroids during the study. (NOTE: oral corticosteroids used for physiologic replacement therapy (e.g. in patients with adrenal insufficiency) and inhaled, nasal, and topical (i.e. dermatological) corticosteroids are allowed).
•Currently on or likely to require treatment with warfarin or warfarin-like anticoagulants, digoxin, or any other medication with a narrow therapeutic index.
•Under treatment with anti-thyroid medication or radioactive iodine for hyperthyroidism.
•Currently treated or likely to require treatment with the following glaucoma medications: ecothiophate, pilocarpine, or carbachol
6. Patient meets one of the following medical exclusions:
•New or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months
•Any of the following in the past 6 months: acute coronary syndrome, cerebral vascular accident, or TIA
•NYHA Class II-IV cardiac status or severe peripheral vascular disease
•Chronic myopathy or a progressive neurological or neuromuscular disorder
•Active nephropathy
•Active liver disease (other than non-alcoholic hepatic steatosis), active viral hepatitis, cirrhosis, or symptomatic gallbladder disease
•HIV positive
•Clinically significant hematological disorder
•History of malignancy < 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer (NOTE: Melanoma, leukemia, myeloproliferative disorders and renal cell carcinoma of any duration are excluded)
•Ocular herpes, uveitis, or iritis within 3 months prior to screening or has a history of recurrent episodes of any of these three conditions.
•Poorly controlled hypertension
•Any other condition which, in the opinion of the investigator, might pose a risk to the patient or make participation not in the patient's best interest, that might confound the results of the study, or interfere with the patient's participation for the full duration of the study
7. Patient has undergone surgery within 30 days prior to Visit 1/Screening Visit or has planned major surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: 1) After 20 weeks, to assess the effect of treatment with MK-0941<br> compared with placebo on A1C when added to basal insulin.<br> 2) To assess the safety and tolerability of MK-0941.<br> ;Secondary Objective: After 20 weeks, to assess the effect of treatment with MK-0941 compared with placebo on fasting plasma glucose when added to basal insulin.;Primary end point(s): Change from baseline in Hb A1C at Week 20.