Phase 1
Completed N=22
A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes (0893-019 AM4)(COMPLETED)
Source: ClinicalTrials.gov NCT00902161 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: Recovery Time (Rt[65] From Insulin-induced Hypoglycemia — 103; 71 minutes — p=0.005
Summary
This study will assess the effect of combined treatment with MK0893 plus propranolol versus placebo plus propranolol on hypoglycemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recovery Time (Rt[65] From Insulin-induced Hypoglycemia |
103; 71 | 0.005 sig |
| SECONDARY Maximum Plasma Concentration (Cmax) and Concentration Average Over 8-12 Hours (C[Ave] 8-12 hr) Post Single Dose MK0893 |
29.18; 26.75 | — |
| SECONDARY Plasma Concentration at 32 Hours (C[32hr]) Post Single Dose MK0893 |
23.69 | — |
| SECONDARY Number of Participants With An Adverse Event (AE) |
10; 4; 9 | — |
| SECONDARY Number of Participants Who Discontinued Study Treatment Due To AEs |
1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participant has Type 2 Diabetes (T2DM)
- Participant is either: Not on an oral antihyperglycemic medication for at least 6 weeks; on a single oral antihyperglycemic medication that is not a peroxisome proliferator-activated gamma (PPAR-gamma) agonist (e.g. Avandia); OR on a combination of no more than two antihyperglycemic medications that are not PPAR-gamma) agonists
- Participant has not received insulin for at least 6 months
- Participant has not been treated with a PPAR-gamma agonist for at least 12 weeks
- Participant has been a nonsmoker for at least 6 months
- Female participants who are non-pregnant and highly unlikely to conceive due to surgical sterilization, post-menopausal status, not heterosexually active, or willing to use 2 birth control methods
Exclusion Criteria
- Participant has a history of stroke, seizures, or neurological disorders
- Participant cannot tolerate insulin or propranolol
- Participant has a history of asthma, emphysema or chronic bronchitis
- Participant is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication within 8 weeks of screening
- Participant is on or may require treatment with drugs that affect the immune system or with corticosteroids
- Participant has a history of heart failure or coronary artery disease
- Participant has a history of uncontrolled high blood pressure
- Participant is Human Immunodeficiency (HIV), hepatitis B or hepatitis C positive
- Participant has a history of Type 1 diabetes
- Participant has a history of hypoglycemia unawareness documented by a blood glucose concentration < 55 mg/dL (3.1 mol/L) without symptoms of hypoglycemia.
Data sourced from ClinicalTrials.gov (NCT00902161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.