Type 2 Diabetes Mellitus
Conditions
Brief summary
This study will examine the safety and efficacy of the addition of omarigliptin in Japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy.
Detailed description
The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week open-label period (Phase B). During Phase A, participants will received either omarigliptin 25 mg or a matching placebo. During Phase, B all participants will receive omarigliptin 25 mg. All participants will remain on a stable dose and administration of a single oral antihyperglycemic basal medication.
Interventions
DRUGOmarigliptin
Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).
Matching placebo to omarigliptin 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has type 2 diabetes mellitus * Has inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy
Exclusion criteria
* History of type 1 diabetes mellitus or a history of ketoacidosis * History of any of the following medications: Thiazolidinediones (TZD) (for participants whose basal medication is not TZD) and/or insulin within 12 weeks prior to study participation, omarigliptin anytime
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A | Up to 24 weeks | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). |
| Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study | Up to 52 weeks | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only. |
| Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A | Up to 24 weeks | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study | Up to 52 weeks | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 | Baseline and Week 24 | HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 HbA1c minus the Week 0 HbA1c. |
Participant flow
Recruitment details
Sixty-seven sites in Japan received IRB approval and were shipped clinical supplies in this study and randomized at least one participant. A total of 772 participants were screened of which 187 participants were excluded. The most common reason for participants not being randomized was screen failure (meeting exclusionary laboratory values).
Pre-assignment details
In Phase A, participants were randomized to receive either omarigliptin (MK-3102) 25 mg once weekly or placebo for 24 weeks in a blinded manner. In Phase B, all participants received open-label omarigliptin 25 mg once weekly for 28 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Omarigliptin 25 mg/SU (Phase A+B) Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study. | 126 |
| Omarigliptin 25 mg/Gln (Phase A+B) Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study. | 65 |
| Omarigliptin 25 mg/BG (Phase A+B) Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study. | 66 |
| Omarigliptin 25 mg/TZD (Phase A+B) Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study. | 65 |
| Omarigliptin 25 mg/α-GI (Phase A+B) Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study. | 67 |
| Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B) Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study. | 63 |
| Placebo/Gln (Phase A) Switching to Omari. 25 mg/Gln (Ph. B) Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study. | 34 |
| Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B) Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG throughout the duration of the study. | 33 |
| Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZD (Phase B) Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study. | 34 |
| Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B) Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study. | 32 |
| Total | 585 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase A (Up to 24 Weeks) | Adverse Event | 0 | 2 | 1 | 2 | 0 | 0 | 1 | 0 | 0 | 1 |
| Phase A (Up to 24 Weeks) | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase A (Up to 24 Weeks) | Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Phase A (Up to 24 Weeks) | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase A (Up to 24 Weeks) | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Phase B (Week 25 to Week 52) | Adverse Event | 2 | 1 | 1 | 2 | 0 | 1 | 1 | 0 | 2 | 0 |
| Phase B (Week 25 to Week 52) | Physician Decision | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase B (Week 25 to Week 52) | Withdrawal by Subject | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Omarigliptin 25 mg/SU (Phase A+B) | Omarigliptin 25 mg/Gln (Phase A+B) | Omarigliptin 25 mg/BG (Phase A+B) | Omarigliptin 25 mg/TZD (Phase A+B) | Omarigliptin 25 mg/α-GI (Phase A+B) | Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B) | Placebo/Gln (Phase A) Switching to Omari. 25 mg/Gln (Ph. B) | Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B) | Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZD (Phase B) | Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 63 Years STANDARD_DEVIATION 9 | 59 Years STANDARD_DEVIATION 11 | 59 Years STANDARD_DEVIATION 9 | 61 Years STANDARD_DEVIATION 10 | 61 Years STANDARD_DEVIATION 11 | 63 Years STANDARD_DEVIATION 11 | 61 Years STANDARD_DEVIATION 10 | 57 Years STANDARD_DEVIATION 9 | 61 Years STANDARD_DEVIATION 9 | 61 Years STANDARD_DEVIATION 11 | 61 Years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 35 Participants | 19 Participants | 20 Participants | 23 Participants | 21 Participants | 18 Participants | 7 Participants | 10 Participants | 7 Participants | 9 Participants | 169 Participants |
| Sex: Female, Male Male | 91 Participants | 46 Participants | 46 Participants | 42 Participants | 46 Participants | 45 Participants | 27 Participants | 23 Participants | 27 Participants | 23 Participants | 416 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 33 / 126 | 19 / 65 | 22 / 66 | 18 / 65 | 19 / 67 | 62 / 196 | 58 / 126 | 29 / 65 | 33 / 66 | 30 / 65 | 26 / 67 | 60 / 191 |
| serious Total, serious adverse events | 3 / 126 | 1 / 65 | 1 / 66 | 4 / 65 | 0 / 67 | 4 / 196 | 6 / 126 | 3 / 65 | 2 / 66 | 4 / 65 | 1 / 67 | 7 / 191 |
Outcome results
Primary
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time frame: Up to 24 weeks
Population: The ASaT population was defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omarigliptin 25 mg/SU (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A | 0 Percentage of Participants |
| Omarigliptin 25 mg/Gln (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A | 3.1 Percentage of Participants |
| Omarigliptin 25 mg/BG (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A | 0 Percentage of Participants |
| Omarigliptin 25 mg/TZD (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A | 3.1 Percentage of Participants |
| Omarigliptin 25 mg/α-GI (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A | 0 Percentage of Participants |
| Placebo/SU (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A | 0 Percentage of Participants |
| Placebo/Gln. (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A | 2.9 Percentage of Participants |
| Placebo/BG (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A | 0 Percentage of Participants |
| Placebo/TZD (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A | 0 Percentage of Participants |
| Placebo/α-GI (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A | 3.1 Percentage of Participants |
Primary
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.
Time frame: Up to 52 weeks
Population: The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omarigliptin 25 mg/SU (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study | 0.8 Percentage of participants |
| Omarigliptin 25 mg/Gln (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study | 4.6 Percentage of participants |
| Omarigliptin 25 mg/BG (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study | 1.5 Percentage of participants |
| Omarigliptin 25 mg/TZD (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study | 6.2 Percentage of participants |
| Omarigliptin 25 mg/α-GI (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study | 0 Percentage of participants |
| Placebo/SU (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study | 1.6 Percentage of participants |
| Placebo/Gln. (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study | 0 Percentage of participants |
| Placebo/BG (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study | 0 Percentage of participants |
| Placebo/TZD (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study | 2.9 Percentage of participants |
| Placebo/α-GI (Phase A) | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study | 0 Percentage of participants |
Primary
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).
Time frame: Up to 24 weeks
Population: All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omarigliptin 25 mg/SU (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A | 59.5 Percentage of participants |
| Omarigliptin 25 mg/Gln (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A | 53.8 Percentage of participants |
| Omarigliptin 25 mg/BG (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A | 54.5 Percentage of participants |
| Omarigliptin 25 mg/TZD (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A | 60.0 Percentage of participants |
| Omarigliptin 25 mg/α-GI (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A | 50.7 Percentage of participants |
| Placebo/SU (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A | 60.3 Percentage of participants |
| Placebo/Gln. (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A | 52.9 Percentage of participants |
| Placebo/BG (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A | 63.6 Percentage of participants |
| Placebo/TZD (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A | 52.9 Percentage of participants |
| Placebo/α-GI (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A | 53.1 Percentage of participants |
Primary
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.
Time frame: Up to 52 weeks
Population: The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omarigliptin 25 mg/SU (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study | 76.2 Percentage of participants |
| Omarigliptin 25 mg/Gln (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study | 75.4 Percentage of participants |
| Omarigliptin 25 mg/BG (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study | 80.3 Percentage of participants |
| Omarigliptin 25 mg/TZD (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study | 84.6 Percentage of participants |
| Omarigliptin 25 mg/α-GI (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study | 68.7 Percentage of participants |
| Placebo/SU (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study | 56.5 Percentage of participants |
| Placebo/Gln. (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study | 59.4 Percentage of participants |
| Placebo/BG (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study | 66.7 Percentage of participants |
| Placebo/TZD (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study | 58.8 Percentage of participants |
| Placebo/α-GI (Phase A) | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study | 53.3 Percentage of participants |
Secondary
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 HbA1c minus the Week 0 HbA1c.
Time frame: Baseline and Week 24
Population: Full Analysis Set (FAS), comprised of all participants who received at least one study drug and have a baseline or post-randomization measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Omarigliptin 25 mg/SU (Phase A) | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 | -0.84 Percent HbA1C |
| Omarigliptin 25 mg/Gln (Phase A) | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 | -0.68 Percent HbA1C |
| Omarigliptin 25 mg/BG (Phase A) | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 | -0.94 Percent HbA1C |
| Omarigliptin 25 mg/TZD (Phase A) | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 | -0.88 Percent HbA1C |
| Omarigliptin 25 mg/α-GI (Phase A) | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 | -0.74 Percent HbA1C |
| Placebo/SU (Phase A) | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 | 0.09 Percent HbA1C |
| Placebo/Gln. (Phase A) | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 | 0.30 Percent HbA1C |
| Placebo/BG (Phase A) | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 | -0.02 Percent HbA1C |
| Placebo/TZD (Phase A) | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 | 0.28 Percent HbA1C |
| Placebo/α-GI (Phase A) | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 | 0.06 Percent HbA1C |
p-value: <0.00195% CI: [-1.1, -0.75]Constrained longitudinal data analysis
p-value: <0.00195% CI: [-1.37, -0.6]Constrained longitudinal data analysis
p-value: <0.00195% CI: [-1.29, -0.56]Constrained longitudinal data analysis
p-value: <0.00195% CI: [-1.45, -0.88]Constrained longitudinal data analysis
p-value: <0.00195% CI: [-1.06, -0.54]Constrained longitudinal data analysis