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CompletedNCT00631488Updated Jan 2, 2017Results posted

A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)

A Phase 2 interventional study of MK-0893 and Sitagliptin in Diabetes Mellitus, Type 2, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-01-02.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study summary

This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 146 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy

Exclusion criteria

Exclusion Criteria:

  • Participants have a history of Type 1 Diabetes Mellitus
  • Participants taking insulin or thiazolidinediones (TZDs: peroxisome proliferator-activated receptor [PPAR]-gamma agonists)
  • Participants who have a contraindication to metformin or sitagliptin
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
146 participants (actual)

Study arms

  • Experimental
    MK-0893 + Sitagliptin

    Drug: MK-0893 · Drug: Sitagliptin · Drug: Placebo for Metformin

  • Experimental
    MK-0893 + Metformin

    Drug: MK-0893 · Drug: Metformin · Drug: Placebo for Sitagliptin

  • Active comparator
    Sitagliptin + Metformin

    Drug: Sitagliptin · Drug: Metformin · Drug: Placebo for MK-0893

Interventions

  • DrugMK-0893

    Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks).

  • DrugSitagliptin

    Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).

    Also known as: JANUVIA™, MK0431

  • DrugMetformin

    Metformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks).

    Also known as: GLUCOPHAGE®

  • DrugPlacebo for MK-0893

    Matching placebo for MK-0893 was orally administered for the loading dose (200 mg) and for the following daily treatment (40 mg) over the 4 week double blind treatment period.

  • DrugPlacebo for Sitagliptin

    Matching placebo for Sitagliptin (100 mg) administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).

  • DrugPlacebo for Metformin

    Metformin-matched placebo taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin-matched placebo then administered throughout the double-blind treatment period (4 weeks).

06

What researchers measure

Primary outcomes

  1. Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels

    Time frame: BL, 4 weeks (end of double-blind treatment period)

Secondary outcomes

  1. Change From BL to Week 4 in Fasting Plasma Glucose (FPG)

    Time frame: BL, 4 weeks (end of double-blind treatment period)

  2. Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)

    Time frame: BL, 4 weeks (end of double-blind treatment period)

  3. Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC

    Glucagon-Like Peptide-1 (GLP-1) is an incretin hormone that acts as a potent insulin secretegogue in response to nutrient ingestion and stimulates glucose disposition. The total AUC of Total GLP-1 levels was calculated from blood sample data measured after the morning meal.

    Time frame: BL, 4 weeks (end of double-blind treatment period)

  4. Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC

    GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. The total AUC of Active GLP-1 levels was calculated from blood sample data measured after the morning meal.

    Time frame: BL, 4 weeks (end of double-blind treatment period)

07

Results

Posted Feb 17, 2012

Participant flow

Participant flow — Overall Study
MilestoneMK-0893 + SitagliptinMK-0893 + MetforminSitagliptin + Metformin
Started484949
Completed post-treatment period444747
Completed444747
Not completed422
Withdrew: Adverse event100
Withdrew: Lost to follow-up220
Withdrew: Physician decision101
Withdrew: Protocol violation001

Outcome measures

PrimaryChange From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels
Time frame:
BL, 4 weeks (end of double-blind treatment period)
Reported as:
Least squares mean · mg/dL
Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels
mg/dLMK-0893 + SitagliptinMK-0893 + MetforminSitagliptin + Metformin
Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels-85.7 ± 4.6-117.4 ± 4.6-99.6 ± 4.6
Statistical analysis
  • MK-0893 + Sitagliptin vs Sitagliptin + Metformin · Longitudinal Data Analysis · p = 0.002 · Mean difference (final values): 13.9 · 95% CI 5.2 to 22.7
  • MK-0893 + Metformin vs Sitagliptin + Metformin · Longitudinal Data Analysis · p = <0.001 · Mean difference (final values): -17.8 · 95% CI -26.5 to -9.2
SecondaryChange From BL to Week 4 in Fasting Plasma Glucose (FPG)
Time frame:
BL, 4 weeks (end of double-blind treatment period)
Reported as:
Least squares mean · mg/dL
Change From BL to Week 4 in Fasting Plasma Glucose (FPG)
mg/dLMK-0893 + SitagliptinMK-0893 + MetforminSitagliptin + Metformin
Change From BL to Week 4 in Fasting Plasma Glucose (FPG)-73.7 ± 4.4-101.9 ± 4.3-82.8 ± 4.3
Statistical analysis
  • MK-0893 + Sitagliptin vs Sitagliptin + Metformin · Longitudinal Data Analysis · p = 0.050 · Mean difference (final values): 9.1 · 95% CI 0.0 to 18.2
  • MK-0893 + Metformin vs Sitagliptin + Metformin · Longitudinal Data Analysis · p = <0.001 · Mean difference (final values): -19.1 · 95% CI -28.0 to -10.1
SecondaryChange From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)
Time frame:
BL, 4 weeks (end of double-blind treatment period)
Reported as:
Least squares mean · mg.h/dL
Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)
mg.h/dLMK-0893 + SitagliptinMK-0893 + MetforminSitagliptin + Metformin
Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)-187.7 ± 11.4-254.9 ± 11.1-210.3 ± 11.4
Statistical analysis
  • MK-0893 + Sitagliptin vs Sitagliptin + Metformin · Longitudinal Data Analysis · p = 0.056 · Mean difference (final values): 22.6 · 95% CI -0.6 to 45.8
  • MK-0893 + Metformin vs Sitagliptin + Metformin · Longitudinal Data Analysis · p = <0.001 · Mean difference (final values): -44.6 · 95% CI -67.3 to -21.8
SecondaryChange From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC

Glucagon-Like Peptide-1 (GLP-1) is an incretin hormone that acts as a potent insulin secretegogue in response to nutrient ingestion and stimulates glucose disposition. The total AUC of Total GLP-1 levels was calculated from blood sample data measured after the morning meal.

Time frame:
BL, 4 weeks (end of double-blind treatment period)
Reported as:
Least squares mean · pmol*h/L
Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC
pmol*h/LMK-0893 + SitagliptinMK-0893 + MetforminSitagliptin + Metformin
Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC7.4 ± 1.016.4 ± 1.03.2 ± 1.0
Statistical analysis
  • MK-0893 + Sitagliptin vs Sitagliptin + Metformin · Longitudinal Data Analysis · p = 0.001 · Mean difference (final values): 4.2 · 95% CI 1.7 to 6.7
  • MK-0893 + Metformin vs Sitagliptin + Metformin · Longitudinal Data Analysis · p = <0.001 · Mean difference (final values): 13.2 · 95% CI 10.7 to 15.7
SecondaryChange From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC

GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. The total AUC of Active GLP-1 levels was calculated from blood sample data measured after the morning meal.

Time frame:
BL, 4 weeks (end of double-blind treatment period)
Reported as:
Least squares mean · pmole*h/L
Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC
pmole*h/LMK-0893 + SitagliptinMK-0893 + MetforminSitagliptin + Metformin
Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC11.0 ± 1.16.3 ± 1.117.6 ± 1.1
Statistical analysis
  • MK-0893 + Sitagliptin vs Sitagliptin + Metformin · Longitudinal Data Analysis · p = <0.001 · Mean difference (final values): -6.7 · 95% CI -9.5 to -3.8
  • MK-0893 + Metformin vs Sitagliptin + Metformin · Longitudinal Data Analysis · p = <0.001 · Mean difference (final values): -11.3 · 95% CI -14.1 to -8.5

Adverse events

Non-serious events are listed at a 5.0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MK-0893 + Sitagliptin—0/48 (0%)7/48 (14.6%)
MK-0893 + Metformin—0/49 (0%)10/49 (20.4%)
Sitagliptin + Metformin—0/49 (0%)8/49 (16.3%)
Most frequent other events
Most frequent other events
EventMK-0893 + SitagliptinMK-0893 + MetforminSitagliptin + Metformin
diarrhoeaGastrointestinal disorders1/486/496/49
upper respiratory tract infectionInfections and infestations4/481/491/49
nauseaGastrointestinal disorders2/484/492/49

Baseline characteristics

Age, Continuous
Age, Continuous(years)MK-0893 + SitagliptinMK-0893 + MetforminSitagliptin + MetforminTotal
Mean53.6 ± 8.052.0 ± 9.753.8 ± 8.753.2 ± 8.8
Gender
Gender(Participants)MK-0893 + SitagliptinMK-0893 + MetforminSitagliptin + MetforminTotal
Female16261557
Male32233489
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00631488
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Mar 7, 2008
Start date
Feb 2008
Primary completion
Jan 2009
Completion
Jan 2009
Results posted
Feb 17, 2012
Last update
Jan 2, 2017

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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