Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking insulin for Type 2 Diabetes.
Interventions
DRUGMK-0941
MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.
DRUGPlacebo
Placebo tablets, taken 3 times daily.
DRUGInsulin
Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participant has Type 2 Diabetes Mellitus
Exclusion criteria
* Participant has a history of Type 1 Diabetes Mellitus or ketoacidosis * Participant is on a weight loss program and is not in the maintenance phase or is taking a weight loss medication * Participant has had surgery within 30 days of starting the study or has planned major surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) Level | Baseline (Day 1) and End of Treatment (Week 20) | HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels. |
| Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic) | From first dose of study drug (Week 0) to last dose of study drug (Week 20) | Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants receiving Placebo tablets 3 times daily plus insulin injection once daily | 34 |
| MK-0941 Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily | 34 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Creatinine/Creatinine Clearance | 0 | 2 |
| Overall Study | Hyperglycemia | 1 | 1 |
| Overall Study | Lack of Efficacy | 2 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | MK-0941 | Total |
|---|---|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 8.8 | 54.1 years STANDARD_DEVIATION 10.2 | 54.8 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 19 Participants | 18 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 34 | 11 / 34 |
| serious Total, serious adverse events | 1 / 34 | 1 / 34 |
Outcome results
Primary
Change From Baseline in Hemoglobin A1c (HbA1c) Level
HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.
Time frame: Baseline (Day 1) and End of Treatment (Week 20)
Population: Full Analysis Set Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo) and had a baseline or post-randomization measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline in Hemoglobin A1c (HbA1c) Level | -0.15 % HbA1c |
| MK-0941 | Change From Baseline in Hemoglobin A1c (HbA1c) Level | -0.26 % HbA1c |
p-value: 0.74595% CI: [-0.81, 0.58]Longitudinal Data Analysis (LDA) model
Primary
Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)
Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy.
Time frame: From first dose of study drug (Week 0) to last dose of study drug (Week 20)
Population: All Participants as Treated Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic) | 6 participants |
| MK-0941 | Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic) | 8 participants |
Comparison: Between-treatment difference (MK-0941 group minus Placebo group) in the percentage of participants who experienced one or more episodes of hypoglycemia.p-value: 0.53795% CI: [-13.7, 25.4]Miettinen & Nurminen method