Adults 21 to 65, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4Primary· Baseline and Week 4
Blood samples were collected 30 minutes prior to all meals, and 15, 30, 60, 90, 120, 180 minutes post-meal, then and at midnight, 3 AM, and the next morning at 6:30 AM and 7:30 AM. A 24-hour weighted mean glucose (WMG) was determined by averaging multiple plasma glucose measurements over a 24-hour period.
Group
Value
95% CI
MK-0893 (40 mg)
-37.9
-47.1 – -28.8
MK-0893 (120 mg)
-65.7
-74.8 – -56.5
Metformin (2000 mg)
-38.1
-47.0 – -29.2
Placebo
-12.0
-20.7 – -3.4
Number of Participants Experiencing an Adverse Event (AE)Primary· Up to 42 days
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Group
Value
95% CI
MK-0893 (40 mg)
3
MK-0893 (120 mg)
7
Metformin (2000 mg)
9
Placebo
8
Number of Participants Discontinuing Study Treatment Due to an AEPrimary· Up to 28 days
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Group
Value
95% CI
MK-0893 (40 mg)
0
MK-0893 (120 mg)
1
Metformin (2000 mg)
0
Placebo
0
Change From Baseline in Fasting Plasma Glucose (FPG)Secondary· Baseline and Week 4
Plasma Glucose levels were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Group
Value
95% CI
MK-0893 (40 mg)
-32.5
-45.1 – -19.8
MK-0893 (120 mg)
-57.7
-70.3 – -45.1
Metformin (2000 mg)
-22.8
-35.0 – -10.5
Placebo
-14.1
-26.1 – -2.2
Change From Baseline in Fructosamine at Week 4Secondary· Baseline and Week 4
Fructosamine levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Group
Value
95% CI
MK-0893 (40 mg)
NA
NA – NA
MK-0893 (120 mg)
NA
NA – NA
Metformin (2000 mg)
NA
NA – NA
Placebo
NA
NA – NA
Change From Baseline in Fasting C-peptide at Week 4Secondary· Baseline and Week 4
Fasting C-peptide levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Group
Value
95% CI
MK-0893 (40 mg)
0.1
-0.5 – 0.7
MK-0893 (120 mg)
-0.3
-0.8 – 0.3
Metformin (2000 mg)
-0.1
-0.6 – 0.5
Placebo
-0.0
-0.6 – 0.5
Change From Baseline in Fasting Insulin at Week 4Secondary· Baseline and Week 4
Fasting insulin levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Group
Value
95% CI
MK-0893 (40 mg)
NA
NA – NA
MK-0893 (120 mg)
NA
NA – NA
Metformin (2000 mg)
NA
NA – NA
Placebo
NA
NA – NA
Change From Baseline in 2-hour Post-prandial Glucose Excursion at Week 4Secondary· Baseline and Week 4
2-hour post-prandial glucose excursion is the change in glucose concentration in the blood 2 hours after a meal. Change from baseline in 2-hour post-prandial glucose excursion at Week 4 is defined as Week 4 minus baseline.
Group
Value
95% CI
MK-0893 (40 mg)
-10.5
-20.2 – -0.8
MK-0893 (120 mg)
-15.3
-25.1 – -5.5
Metformin (2000 mg)
-29.0
-38.4 – -19.5
Placebo
-2.8
-12.2 – 6.5
Change From Baseline in 3-hour Area Under the Plasma Concentration Versus Time Curve (AUC) for Glucose at Week 4Secondary· Baseline and Week 4
Blood samples collected for glucose 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for Glucose was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Group
Value
95% CI
MK-0893 (40 mg)
-128.8
-169.5 – -88.2
MK-0893 (120 mg)
-230.2
-270.5 – -189.9
Metformin (2000 mg)
-136.7
-175.7 – -97.6
Placebo
-39.0
-77.3 – -0.8
Change From Baseline in 3-hour AUC for C-peptide at Week 4Secondary· Baseline and Week 4
Blood samples were collected for C-peptide 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for C-peptide was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Group
Value
95% CI
MK-0893 (40 mg)
1.0
-0.9 – 2.9
MK-0893 (120 mg)
-0.5
-2.5 – 1.4
Metformin (2000 mg)
-0.2
-2.1 – 1.6
Placebo
-0.1
-1.9 – 1.8
Change From Baseline in 3-hour Insulin Total AUC at Week 4Secondary· Baseline and Week 4
Blood samples were collected for insulin 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour Insulin Total AUC was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Group
Value
95% CI
MK-0893 (40 mg)
5.3
-15.5 – 26.1
MK-0893 (120 mg)
6.1
-15.3 – 27.6
Metformin (2000 mg)
1.2
-18.4 – 20.7
Placebo
7.8
-11.2 – 26.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 42 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will reduce 24-hour weighted mean glucose (WMG) significantly more than placebo.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 5 September 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02004886.