Diabetes Mellitus, Type 2Phase 2NCT01059825
Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)
A Phase 2 study testing Ertugliflozin 1 mg, Ertugliflozin 5 mg and Ertugliflozin 25 mg in people with Diabetes Mellitus, Type 2, run by Merck Sharp & Dohme LLC.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Ertugliflozin 1 mg, Ertugliflozin 5 mg and Ertugliflozin 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2010to 20 Jan 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants with type 1 diabetes, heart attack or stroke in last 6-months, uncontrolled blood pressure, significant kidney disease
About this study
Official 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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Placebo to Ertugliflozin, Ertugliflozin 1 mg, Ertugliflozin 5 mg, Ertugliflozin 25 mg, Sitagliptin 100 mg
- Keywords
- Phase 2, safety and efficacy study with ertugliflozin (PF-04971729, MK-8835), Type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo to ErtugliflozinDrug
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Ertugliflozin 1 mgDrug
Tablet, 1 mg, once daily for 84 days
Ertugliflozin 5 mgDrug
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
Ertugliflozin 25 mgDrug
Tablet, 25 mg, once daily for 84 days
Sitagliptin 100 mgDrug
Also called Januvia®, Tesavel®, Xelevia®, Ristaben®
Tablet, 100 mg, once daily for 84 days
Placebo to SitagliptinDrug
Tablet, matching placebo to 100 mg, once daily for 84 days
MetforminDrug
Also called Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
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).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days Receives: Drug: Placebo to Ertugliflozin; Drug: Placebo to Sitagliptin; Drug: Metformin |
| Ertugliflozin 1 mg | Experimental | Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days Receives: Drug: Placebo to Ertugliflozin; Drug: Ertugliflozin 1 mg; Drug: Placebo to Sitagliptin; Drug: Metformin |
| Ertugliflozin 5 mg | Experimental | Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days Receives: Drug: Placebo to Ertugliflozin; Drug: Ertugliflozin 5 mg; Drug: Placebo to Sitagliptin; Drug: Metformin |
| Ertugliflozin 10 mg | Experimental | Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days Receives: Drug: Placebo to Ertugliflozin; Drug: Ertugliflozin 5 mg; Drug: Placebo to Sitagliptin; Drug: Metformin |
| Ertugliflozin 25 mg | Experimental | Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days Receives: Drug: Placebo to Ertugliflozin; Drug: Ertugliflozin 25 mg; Drug: Placebo to Sitagliptin; Drug: Metformin |
| Sitagliptin 100 mg | Active comparator | Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days Receives: Drug: Placebo to Ertugliflozin; Drug: Sitagliptin 100 mg; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Hemoglobin A1c (HbA1c)
HbA1c is measured as percent.
Measured: Baseline
Change From Baseline in HbA1c at 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]).
Measured: Baseline and Week 12
Secondary outcomes (27)
Change From Baseline in HbA1C at Week 2
HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
Measured: Baseline and Week 2
Change From Baseline in HbA1c at Week 4
HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
Measured: Baseline and Week 4
Change From Baseline in HbA1c at Week 8
HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
Measured: Baseline and Week 8
Baseline Body Weight
Measured: Baseline
Percent Change From Baseline in Body Weight at 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).
Measured: Baseline and Week 12
Percent Change From Baseline in Body Weight at 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).
Measured: Baseline and Week 2
Percent Change From Baseline in Body Weight at 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).
Measured: Baseline and Week 4
Percent Change From Baseline in Body Weight at 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).
Measured: Baseline and Week 8
Baseline Systolic Blood Pressure
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
Measured: Baseline
Change From Baseline in Systolic Blood Pressure at 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).
Measured: Baseline and Week 12
Change From Baseline in Systolic Blood Pressure at 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).
Measured: Baseline and Week 2
Change From Baseline in Systolic Blood Pressure at 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).
Measured: Baseline and Week 4
Change From Baseline in Systolic Blood Pressure at 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).
Measured: Baseline and Week 8
Baseline Diastolic Blood Pressure
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
Measured: Baseline
Change From Baseline in Diastolic Blood Pressure at 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).
Measured: Baseline and Week 12
Change From Baseline in Diastolic Blood Pressure at 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).
Measured: Baseline and Week 2
Change From Baseline in Diastolic Blood Pressure at 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).
Measured: Baseline and Week 4
Change From Baseline in Diastolic Blood Pressure at 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).
Measured: Baseline and Week 8
Baseline Fasting Plasma Glucose
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Measured: Baseline
Change From Baseline in Fasting Plasma Glucose at 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.
Measured: Baseline and Week 12
Change From Baseline in Fasting Plasma Glucose at 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.
Measured: Baseline and Week 2
Change From Baseline in Fasting Plasma Glucose at 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.
Measured: Baseline and Week 4
Change From Baseline in Fasting Plasma Glucose at 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.
Measured: Baseline and Week 8
Percentage of Participants Achieving HbA1c <7% at Week 12
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Measured: Week 12
Percentage of Participants Achieving HbA1C <6.5% at Week 12
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Measured: Week 12
Number of Participants Who Experienced an Advere Event (AE)
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.
Measured: Up to 98 days
Number of Participants Who Discontinued Study Medication Due to an AE
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.
Measured: Up to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study start24 Feb 2010
- Primary completion20 Jan 2011
- Study completion20 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059825
- Sponsor's protocol ID
- 8835-016
- Other IDs
- B1521006, 2009-017131-18, 2009
- Status last verified
- Aug 2018
- First submitted
- 29 Jan 2010
- Last updated
- 13 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Amin NB, Wang X, Jain SM, Lee DS, Nucci G, Rusnak JM. Dose-ranging efficacy and safety study of ertugliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin. Diabetes Obes Metab. 2015 Jun;17(6):591-598. doi: 10.1111/dom.12460. Epub 2015 Mar 31.
PubMed 25754396Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, Sweeney K. Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1297-1306. doi: 10.1002/cpdd.970. Epub 2021 Jul 2.
PubMed 34213819
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01059825
- Acronym / sponsor ID
- 8835-016
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Phase 2, safety and efficacy study with ertugliflozin (PF-04971729, MK-8835), Type 2 diabetes mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 24 Feb 2010 (actual)
- Primary completion
- 20 Jan 2011 (actual)
- Study completion
- 20 Jan 2011 (actual)
- First posted
- 1 Feb 2010 (estimated)
- Results
- Posted 4 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo to Ertugliflozin, Drug: Placebo to Sitagliptin, Drug: MetforminPlacebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days |
| Ertugliflozin 1 mg | Experimental | Drug: Placebo to Ertugliflozin, Drug: Ertugliflozin 1 mg, Drug: Placebo to Sitagliptin, Drug: MetforminErtugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days |
| Ertugliflozin 5 mg | Experimental | Drug: Placebo to Ertugliflozin, Drug: Ertugliflozin 5 mg, Drug: Placebo to Sitagliptin, Drug: MetforminErtugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days |
| Ertugliflozin 10 mg | Experimental | Drug: Placebo to Ertugliflozin, Drug: Ertugliflozin 5 mg, Drug: Placebo to Sitagliptin, Drug: MetforminErtugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days |
| Ertugliflozin 25 mg | Experimental | Drug: Placebo to Ertugliflozin, Drug: Ertugliflozin 25 mg, Drug: Placebo to Sitagliptin, Drug: MetforminErtugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days |
| Sitagliptin 100 mg | Active comparator | Drug: Placebo to Ertugliflozin, Drug: Sitagliptin 100 mg, Drug: MetforminSitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Participants with type 1 diabetes, heart attack or stroke in last 6-months, uncontrolled blood pressure, significant kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo to ErtugliflozinTablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days | Drug | Ertugliflozin 1 mg, Ertugliflozin 10 mg, Ertugliflozin 25 mg, Ertugliflozin 5 mg, Placebo, Sitagliptin 100 mg |
| Ertugliflozin 1 mgTablet, 1 mg, once daily for 84 days | Drug | Ertugliflozin 1 mg |
| Ertugliflozin 5 mgTablet(s), 1 or 2, 5-mg tablets once daily for 84 days | Drug | Ertugliflozin 10 mg, Ertugliflozin 5 mg |
| Ertugliflozin 25 mgTablet, 25 mg, once daily for 84 days | Drug | Ertugliflozin 25 mg |
| Sitagliptin 100 mgAlso: Januvia®, Tesavel®, Xelevia®, Ristaben®Tablet, 100 mg, once daily for 84 days | Drug | Sitagliptin 100 mg |
| Placebo to SitagliptinTablet, matching placebo to 100 mg, once daily for 84 days | Drug | Ertugliflozin 1 mg, Ertugliflozin 10 mg, Ertugliflozin 25 mg, Ertugliflozin 5 mg, Placebo |
| MetforminAlso: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®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). | Drug | Ertugliflozin 1 mg, Ertugliflozin 10 mg, Ertugliflozin 25 mg, Ertugliflozin 5 mg, Placebo, Sitagliptin 100 mg |
Primary outcome
Baseline Hemoglobin A1c (HbA1c)
Time frame: Baseline
HbA1c is measured as percent.
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]).
27 secondary outcomes
Change From Baseline in HbA1C at Week 2
Time frame: Baseline and Week 2
Change From Baseline in HbA1c at Week 4
Time frame: Baseline and Week 4
Change From Baseline in HbA1c at Week 8
Time frame: Baseline and Week 8
Baseline Body Weight
Time frame: Baseline
Percent Change From Baseline in Body Weight at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Body Weight at Week 2
Time frame: Baseline and Week 2
Percent Change From Baseline in Body Weight at Week 4
Time frame: Baseline and Week 4
Percent Change From Baseline in Body Weight at Week 8
Time frame: Baseline and Week 8
Baseline Systolic Blood Pressure
Time frame: Baseline
Change From Baseline in Systolic Blood Pressure at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Systolic Blood Pressure at Week 2
Time frame: Baseline and Week 2
Change From Baseline in Systolic Blood Pressure at Week 4
Time frame: Baseline and Week 4
Change From Baseline in Systolic Blood Pressure at Week 8
Time frame: Baseline and Week 8
Baseline Diastolic Blood Pressure
Time frame: Baseline
Change From Baseline in Diastolic Blood Pressure at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Diastolic Blood Pressure at Week 2
Time frame: Baseline and Week 2
Change From Baseline in Diastolic Blood Pressure at Week 4
Time frame: Baseline and Week 4
Change From Baseline in Diastolic Blood Pressure at Week 8
Time frame: Baseline and Week 8
Baseline Fasting Plasma Glucose
Time frame: Baseline
Change From Baseline in Fasting Plasma Glucose at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Fasting Plasma Glucose at Week 2
Time frame: Baseline and Week 2
Change From Baseline in Fasting Plasma Glucose at Week 4
Time frame: Baseline and Week 4
Change From Baseline in Fasting Plasma Glucose at Week 8
Time frame: Baseline and Week 8
Percentage of Participants Achieving HbA1c <7% at Week 12
Time frame: Week 12
Percentage of Participants Achieving HbA1C <6.5% at Week 12
Time frame: Week 12
Number of Participants Who Experienced an Advere Event (AE)
Time frame: Up to 98 days
Number of Participants Who Discontinued Study Medication Due to an AE
Time frame: Up to 84 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25754396Amin NB, Wang X, Jain SM, Lee DS, Nucci G, Rusnak JM. Dose-ranging efficacy and safety study of ertugliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin. Diabetes Obes Metab. 2015 Jun;17(6):591-598. doi: 10.1111/dom.12460. Epub 2015 Mar 31.
- Derived from this study: PubMed 34213819Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, Sweeney K. Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1297-1306. doi: 10.1002/cpdd.970. Epub 2021 Jul 2.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ertugliflozin 1 mg, Ertugliflozin 5 mg and Ertugliflozin 25 mg in people with Diabetes Mellitus, Type 2, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Hemoglobin A1c (HbA1c) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01059825, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.