NCT00673465

Brief Summary

The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and to determine the influence of race/ethnic origin on therapeutic response.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2008

Typical duration for phase_1 type-2-diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2008

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

February 15, 2017

Completed
Last Updated

September 10, 2018

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

May 5, 2008

Results QC Date

October 13, 2016

Last Update Submit

August 10, 2018

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Pharmacodynamic: Change From Baseline in Mean 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States)

    Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL\*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.

    Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28

  • Pharmacodynamic: Change From Baseline in 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India)

    Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals (breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL\*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.

    Pre-dose (-30 mnutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28

Secondary Outcomes (12)

  • Number of Participants Who Experienced at Least One Adverse Event (Part 1 - United States)

    Up to 14 days after last dose of study drug (up to 98 days)

  • Number of Participants Who Experienced at Least One Adverse Event (Part 2 - India)

    Up to 14 days after last dose of study drug (up to 98 days)

  • Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States)

    Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28

  • Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India)

    Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28

  • Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 1 - United States)

    Baseline and Week 4

  • +7 more secondary outcomes

Study Arms (6)

Treatment sequence 1: SCH 497079 → Placebo → Metformin

EXPERIMENTAL

Participants received SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks followed by metformin daily for 4 weeks.

Drug: SCH 497079Drug: PlaceboDrug: Metformin

Treatment sequence 2: Placebo → Metformin → SCH 497079

EXPERIMENTAL

Participants received placebo daily for 4 weeks followed by metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks.

Drug: SCH 497079Drug: PlaceboDrug: Metformin

Treatment sequence 3: Metformin → SCH 497079 → Placebo

EXPERIMENTAL

Participants received metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks.

Drug: SCH 497079Drug: PlaceboDrug: Metformin

Treatment sequence 4: SCH 497079 → Metformin → Placebo

EXPERIMENTAL

Participants received SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks followed by placebo daily for 4 weeks.

Drug: SCH 497079Drug: PlaceboDrug: Metformin

Treatment sequence 5: Placebo → SCH 49709 → Metformin

EXPERIMENTAL

Participants received placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks.

Drug: SCH 497079Drug: PlaceboDrug: Metformin

Treatment sequence 6: Metformin → Placebo → SCH 497079

EXPERIMENTAL

Participants received metformin daily for 4 weeks followed by placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks.

Drug: SCH 497079Drug: PlaceboDrug: Metformin

Interventions

SCH 497079DRUG

SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks

Treatment sequence 1: SCH 497079 → Placebo → MetforminTreatment sequence 2: Placebo → Metformin → SCH 497079Treatment sequence 3: Metformin → SCH 497079 → PlaceboTreatment sequence 4: SCH 497079 → Metformin → PlaceboTreatment sequence 5: Placebo → SCH 49709 → MetforminTreatment sequence 6: Metformin → Placebo → SCH 497079
PlaceboDRUG

Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks

Treatment sequence 1: SCH 497079 → Placebo → MetforminTreatment sequence 2: Placebo → Metformin → SCH 497079Treatment sequence 3: Metformin → SCH 497079 → PlaceboTreatment sequence 4: SCH 497079 → Metformin → PlaceboTreatment sequence 5: Placebo → SCH 49709 → MetforminTreatment sequence 6: Metformin → Placebo → SCH 497079
MetforminDRUG

Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)

Treatment sequence 1: SCH 497079 → Placebo → MetforminTreatment sequence 2: Placebo → Metformin → SCH 497079Treatment sequence 3: Metformin → SCH 497079 → PlaceboTreatment sequence 4: SCH 497079 → Metformin → PlaceboTreatment sequence 5: Placebo → SCH 49709 → MetforminTreatment sequence 6: Metformin → Placebo → SCH 497079

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>=18 years of age to 65 years of age, of either sex, and having a body mass index (BMI) between 27 and 35, inclusive (USA participants)
  • Clinical laboratory tests (complete blood count, blood chemistry, and urinalysis) within normal limits (excluding glucose and other changes usually associated with diabetes eg, dyslipidemia)
  • Type 2 diabetes mellitus

You may not qualify if:

  • Female participants who are premenopausal or are not surgically sterilized. Participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breast-feeding.
  • Participants who have received insulin therapy within 6 months, prior to Day 1/Period 1 or who require thiazide diuretics, beta-blockers and cyclic hormone therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Limitations and Caveats

Part 2 of the study was not conducted. Part 2 of the study was to be conducted if the analysis of Part 1 indicated a clinically significant decrease in blood glucose in participants type 2 diabetes mellitus compared to placebo.

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2008

First Posted

May 7, 2008

Study Start

April 17, 2008

Primary Completion

December 11, 2008

Study Completion

December 11, 2008

Last Updated

September 10, 2018

Results First Posted

February 15, 2017

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

More information