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Completed

NCT Number: NCT01059825

Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)

MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus. Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with type 2 diabetes on stable doses of background medicines for management of the diabetes; aged 18-70 years; body mass index between 23-45 kg/m^2

Exclusion criteria

  • Participants with type 1 diabetes, heart attack or stroke in last 6-months, uncontrolled blood pressure, significant kidney disease

Treatment and study plan

Placebo to Ertugliflozin

Drug

Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days

Ertugliflozin 1 mg

Drug

Tablet, 1 mg, once daily for 84 days

Ertugliflozin 5 mg

Drug

Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days

Ertugliflozin 25 mg

Drug

Tablet, 25 mg, once daily for 84 days

Sitagliptin 100 mg

Drug

Tablet, 100 mg, once daily for 84 days

Other names: Januvia®, Tesavel®, Xelevia®, Ristaben®

Placebo to Sitagliptin

Drug

Tablet, matching placebo to 100 mg, once daily for 84 days

metformin

Drug

Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).

Other names: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®

Primary outcomes

  1. Baseline Hemoglobin A1c (HbA1c)

    Time frame: Baseline

    HbA1c is measured as percent.

  2. Change From Baseline in HbA1c at Week 12

    Time frame: Baseline and Week 12

    HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward [LOCF]).

Secondary outcomes

  1. Change From Baseline in HbA1C at Week 2

    Time frame: Baseline and Week 2

    HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF).

  2. Change From Baseline in HbA1c at Week 4

    Time frame: Baseline and Week 4

    HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF).

  3. Change From Baseline in HbA1c at Week 8

    Time frame: Baseline and Week 8

    HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF).

  4. Baseline Body Weight

    Time frame: Baseline

  5. Percent Change From Baseline in Body Weight at Week 12

    Time frame: Baseline and Week 12

    The percent change from baseline is the ([Week 12 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).

  6. Percent Change From Baseline in Body Weight at Week 2

    Time frame: Baseline and Week 2

    The percent change from baseline is the ([Week 2 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).

  7. Percent Change From Baseline in Body Weight at Week 4

    Time frame: Baseline and Week 4

    The percent change from baseline is the ([Week 4 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).

  8. Percent Change From Baseline in Body Weight at Week 8

    Time frame: Baseline and Week 8

    The percent change from baseline is the ([Week 8 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).

  9. Baseline Systolic Blood Pressure

    Time frame: Baseline

    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.

  10. Change From Baseline in Systolic Blood Pressure at Week 12

    Time frame: Baseline and Week 12

    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).

  11. Change From Baseline in Systolic Blood Pressure at Week 2

    Time frame: Baseline and Week 2

    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).

  12. Change From Baseline in Systolic Blood Pressure at Week 4

    Time frame: Baseline and Week 4

    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).

  13. Change From Baseline in Systolic Blood Pressure at Week 8

    Time frame: Baseline and Week 8

    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).

  14. Baseline Diastolic Blood Pressure

    Time frame: Baseline

    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.

  15. Change From Baseline in Diastolic Blood Pressure at Week 12

    Time frame: Baseline and Week 12

    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).

  16. Change From Baseline in Diastolic Blood Pressure at Week 2

    Time frame: Baseline and Week 2

    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).

  17. Change From Baseline in Diastolic Blood Pressure at Week 4

    Time frame: Baseline and Week 4

    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).

  18. Change From Baseline in Diastolic Blood Pressure at Week 8

    Time frame: Baseline and Week 8

    Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).

  19. Baseline Fasting Plasma Glucose

    Time frame: Baseline

    Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

  20. Change From Baseline in Fasting Plasma Glucose at Week 12

    Time frame: Baseline and Week 12

    The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

  21. Change From Baseline in Fasting Plasma Glucose at Week 2

    Time frame: Baseline and Week 2

    The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

  22. Change From Baseline in Fasting Plasma Glucose at Week 4

    Time frame: Baseline and Week 4

    The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

  23. Change From Baseline in Fasting Plasma Glucose at Week 8

    Time frame: Baseline and Week 8

    The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

  24. Percentage of Participants Achieving HbA1c <7% at Week 12

    Time frame: Week 12

    Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

  25. Percentage of Participants Achieving HbA1C <6.5% at Week 12

    Time frame: Week 12

    Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

  26. Number of Participants Who Experienced an Advere Event (AE)

    Time frame: Up to 98 days

    An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin.

  27. Number of Participants Who Discontinued Study Medication Due to an AE

    Time frame: Up to 84 days

    An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Pfizer

Registry information

Official study title

A 12-Week, Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Evaluate the Safety, Tolerability and Efficacy Of Once Daily PF-04971729 And Sitagliptin On Glycemic Control And Body Weight In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 1, 2010
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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