Type 2 Diabetes MellitusPhase 2NCT00806585

Dose-ranging Study to Evaluate the Effectiveness and Tolerability of MK0736 in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypertension (0736-007)

A Phase 2 study testing MK-0736 and Comparator: HCTZ in people with Type 2 Diabetes Mellitus and Hypertension, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus, Hypertension
What is being tested?: MK-0736 and Comparator: HCTZ
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 620 participants
Where: No sites listed yet
Study dates: Dec 2008to Jun 2010
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must be 18 to 75 years of age
Type 2 Diabetes Mellitus (Glycohemoglobin [A1CHbA1c]: 7 to 10%)
Hypertension: Diastolic blood pressure (DBP; 85 to 99 mm Hg) and systolic blood pressure (SBP; 120 to 159 mm Hg)
LDL-C < 140 mg/dL
On stable treatment with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)

Who cannot join

History of Type I Diabetes mellitus or ketoacidosis
Patients taking 3 or more blood pressure lowering medications
Have severe chronic heart failure
History of certain diseases or conditions such as cardiac arrhythmias, heart attack, stroke, unstable angina, or decompensated vascular disease
History of cancer within the last 5 years
Human immunodeficiency virus (HIV) Positive

Show all 9Show fewer

Have received treatment with any investigational drugs within the past 30 days
History of alcohol or drug abuse within the past 3 years
Body Mass Index ( BMI) >= 41 kg/m2

About this study

Official title: A Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy & Tolerability of MK0736 When Added to Ongoing Therapy With Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) in Patients With T2DM and Hypertension

The study will assess the efficacy and tolerability of MK0736 in patients with Type 2 Diabetes Mellitus and Hypertension who are on ongoing therapy with Angiotensin-Converting Enzyme or Angiotensin Receptor Blocker. After a 3 to 5 week pre-randomization phase, patients will be randomized to either MK0736 (3 doses), placebo, or hydrochlorothiazide (HCTZ). The study will also include a 3 week, posttreatment follow-up period.

Conditions: Type 2 Diabetes Mellitus, Hypertension
Being tested: MK-0736, Comparator: Placebo, Comparator: HCTZ
Medical subject headings: Diabetes Mellitus, Type 2, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-0736Drug
Comparator: PlaceboDrug
Comparator: HCTZDrug

Study groups in NCT00806585
Study group	Role	What they receive
MK-0736 0.5 mg	Experimental	One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B). Receives: Drug: MK-0736
MK-0736 2.0 mg	Experimental	One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B). Receives: Drug: MK-0736
MK-0736 8.0 mg	Experimental	One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B). Receives: Drug: MK-0736
HCTZ 12.5 mg → MK-0736 8.0 mg	Active comparator	one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B). Receives: Drug: MK-0736; Drug: Comparator: HCTZ
Placebo	Placebo comparator	One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B) Receives: Drug: Comparator: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average of the last 5 measurement was recorded.
Measured: Baseline and Week 12
Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12
Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average the last 5 measurement was recorded.
Measured: Baseline and Week 12

Secondary outcomes (3)

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
LDL-C calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration
Measured: Baseline and Week 12
Change From Baseline in Body Weight at Week 24
Fasting weight was assessed at baseline and after 24 weeks of study drug administration and was measured after voiding, with shoes and socks off, wearing clinic gown to reduce variability and maintain consistency. Same standardized digital scale was used throughout the study.
Measured: Baseline and Week 24
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
HbA1c reported as a % and was measured at baseline and after 24 weeks of study drug administration
Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Jun 2010

First posted11 Dec 2008 (estimated)
Study startDec 2008
Primary completionMar 2010
Study completionJun 2010

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.
Other trials for Type 2 Diabetes MellitusStudies 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: 620 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00806585
Sponsor's protocol ID: 0736-007
Other IDs: MK0736-007, 2008_600
Status last verified: Sep 2015
First submitted: 10 Dec 2008
Last updated: 21 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy & Tolerability of MK0736 When Added to Ongoing Therapy With Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) in Patients With T2DM and Hypertension
ClinicalTrials.gov ID: NCT00806585
Acronym / sponsor ID: 0736-007
Conditions: Type 2 Diabetes Mellitus, Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 620 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Mar 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 11 Dec 2008 (estimated)
Results: Posted 11 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
MK-0736 0.5 mg	Experimental	Drug: MK-0736One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
MK-0736 2.0 mg	Experimental	Drug: MK-0736One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
MK-0736 8.0 mg	Experimental	Drug: MK-0736One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
HCTZ 12.5 mg → MK-0736 8.0 mg	Active comparator	Drug: MK-0736, Drug: Comparator: HCTZone 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
Placebo	Placebo comparator	Drug: Comparator: PlaceboOne placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Must be 18 to 75 years of age
Type 2 Diabetes Mellitus (Glycohemoglobin [A1CHbA1c]: 7 to 10%)
Hypertension: Diastolic blood pressure (DBP; 85 to 99 mm Hg) and systolic blood pressure (SBP; 120 to 159 mm Hg)
LDL-C < 140 mg/dL
On stable treatment with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)

Key exclusion criteria (9 listed)

History of Type I Diabetes mellitus or ketoacidosis
Patients taking 3 or more blood pressure lowering medications
Have severe chronic heart failure
History of certain diseases or conditions such as cardiac arrhythmias, heart attack, stroke, unstable angina, or decompensated vascular disease
History of cancer within the last 5 years

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
MK-0736	Drug	HCTZ 12.5 mg → MK-0736 8.0 mg, MK-0736 0.5 mg, MK-0736 2.0 mg, MK-0736 8.0 mg
Comparator: Placebo	Drug	Placebo
Comparator: HCTZ	Drug	HCTZ 12.5 mg → MK-0736 8.0 mg

Primary outcome

Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Time frame: Baseline and Week 12
Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average of the last 5 measurement was recorded.
Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12
Time frame: Baseline and Week 12
Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average the last 5 measurement was recorded.

3 secondary outcomes

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Body Weight at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 11 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-0736 0.5 mg	137	105
MK-0736 2.0 mg	134	103
MK-0736 8.0 mg	141	109
HCTZ 12.5 mg → MK-0736 8.0 mg	71	56
Placebo	137	106

Primary outcome: Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12

Time frame: Baseline and Week 12. Least squares mean (Standard Error). Unit: mmHg

Measure	MK-0736 0.5 mg n = 135	MK-0736 2.0 mg n = 132	MK-0736 8.0 mg n = 140	HCTZ 12.5 mg → MK-0736 8.0 mg n = 70	Placebo n = 136
Value	-5.8 (0.7)	-5.7 (0.7)	-6.7 (0.7)	-7.7 (1.0)	-5.6 (0.7)

MK-0736 8.0 mg vs Placebo: Difference in least squares means: -1.1 (95% CI -3.1 to 0.8), p = 0.253, Constrained longitudinal data analysis
MK-0736 2.0 mg vs Placebo: Difference in least squares means: -0.1 (95% CI -2.1 to 1.9), p = 0.919, Constrained longitudinal data analysis
MK-0736 0.5 mg vs Placebo: Difference in least squares means: -0.2 (95% CI -2.2 to 1.8), p = 0.829, Constrained longitudinal data analysis

Population analysed: Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)

Primary outcome: Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12

Time frame: Baseline and Week 12. Least squares mean (Standard Error). Unit: mmHg

Measure	MK-0736 0.5 mg n = 135	MK-0736 2.0 mg n = 132	MK-0736 8.0 mg n = 140	HCTZ 12.5 mg → MK-0736 8.0 mg n = 70	Placebo n = 136
Value	-5.7 (1.1)	-7.2 (1.1)	-6.3 (1.1)	-12.4 (1.5)	-5.4 (1.2)

MK-0736 8.0 mg vs Placebo: Difference in least squares means: -0.9 (95% CI -4.0 to 2.1), p = 0.543, Constrained longitudinal data analysis
MK-0736 2.0 mg vs Placebo: Difference in least squares means: -1.8 (95% CI -4.9 to 1.3), p = 0.246, Constrained longitudinal data analysis
MK-0736 0.5 mg vs Placebo: Difference in least squares means: -0.4 (95% CI -3.5 to 2.7), p = 0.821, Constrained longitudinal data analysis

Population analysed: Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 76 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-0736 0.5 mg	9 of 137 (6.6%)	46 of 137 (33.6%)	Not reported
MK-0736 2.0 mg	7 of 134 (5.2%)	54 of 134 (40.3%)	Not reported
MK-0736 8.0 mg	6 of 141 (4.3%)	54 of 141 (38.3%)	Not reported
HCTZ 12.5 mg → MK-0736 8.0 mg	0 of 71 (0%)	25 of 71 (35.2%)	Not reported
Placebo	5 of 137 (3.6%)	43 of 137 (31.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes Mellitus

Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
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Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
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Not yet recruiting
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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 Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK-0736 and Comparator: HCTZ in people with Type 2 Diabetes Mellitus and Hypertension, 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 21 Sep 2015. 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 11 Dec 2013). 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?

Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12 (time frame: Baseline and Week 12). 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 NCT00806585.

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 21 Sep 2015.