Type 2 Diabetes MellitusPhase 4NCT01709305

A Study of the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose When Added to Sitagliptin + Metformin Combination Therapy in Chinese Participants With Diabetes (MK-0431-313)

A Phase 4 study testing Metformin, Sitagliptin and Acarbose in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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
What is being tested?: Metformin, Sitagliptin and Acarbose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5,570 participants
Where: No sites listed yet
Study dates: 8 Nov 2012to 17 Apr 2015
Phase: Phase 4
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

Has Type 2 Diabetes Mellitus;
Agrees to use an effective method of contraception or must not otherwise be at risk of becoming pregnant (female participants).

Who cannot join

Has a history of type 1 diabetes mellitus or a history of ketoacidosis;
Has been treated with insulin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a Glucagon-like peptide-1 (GLP-1) mimetic or analogue before;
Is on a weight loss program (not in maintenance phase), has started a weight loss medication, or has undergone bariatric surgery within 12 months;
Has undergone a surgical procedure within 4 weeks;
Has had new or worsening signs or symptoms of coronary heart disease or congestive heart failure within past 3 months, or has acute coronary syndrome, coronary artery intervention, or stroke or transient ischemic neurological disorder;
Has a medical history of active liver disease, including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease;

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Has poorly controlled hypertension;
Has severe peripheral vascular disease;
Has human immunodeficiency virus (HIV);
Has had a clinically important hematological disorder;
Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking;
Has a history of intolerance or hypersensitivity or any contraindication to study medications (including sitagliptin, metformin, glimepiride, repaglinide, acarbose or gliclazide) based upon the Chinese label;
Is on or likely to require treatment with ≥2 consecutive weeks or repeated courses of pharmacologic doses of corticosteroids (other than inhaled, nasal, or topical corticosteroids);
Is pregnant or breast feeding or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study drug (female participants).

About this study

Official title: A Multicenter, Randomized, Active-Controlled, Open-label Clinical Trial to Evaluate the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose as a Third OAHA on Top of Sitagliptin+Metformin Combination Therapy in Chinese Patients With Type 2 Diabetes Mellitus

To assess the effect of adding acarbose or repaglinide or gliclazide to sitagliptin plus metformin, compared to adding glimepiride, on glycemic improvements in Type 2 Diabetes Mellitus (T2DM) participants who require the addition of a third oral anti-hyperglycemic agent (OAHA) according to China Guideline for Type 2 Diabetes. The three co-primary hypotheses are that after 24 weeks of treatment in phase 2, the mean change from baseline in hemoglobin A1c (A1c) in participants receiving either (1)acarbose or (2)repaglinide or (3)gliclazide added to sitagliptin and metformin combination is non-inferior to that of participants receiving glimepiride added to sitagliptin and metformin combination. The study would be declared successful if at least one of the three primary hypotheses was met.

Read the detailed description

Participants coming on study will be stabilized to a standardized metformin dose: this may take about 10 weeks, and then combination therapy with metformin + sitagliptin will begin during Phase 1 (Week 0 through Week 20). If a participant has already been on a stabilized metformin dose, they will start immediately on combination therapy with metformin + sitagliptin for 20 weeks (Phase 1).

In Phase 2, participants who have failed to achieve adequate glycemic control (A1c ≥ 7% and ≤ 10% at Week 16 and fasting finger stick glucose ≥130 mg/dL and ≤280 mg/dL at Week 20) will be randomized to receive add-on therapy with glimepiride, repaglinide, acarbose, or gliclazide for 24 weeks (Week 20 through Week 44).

Conditions: Type 2 Diabetes Mellitus
Being tested: Metformin, Sitagliptin, Acarbose, Repaglinide, Glimepiride
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.

MetforminDrug
Also called Fortamet®, Glucophage®, Glucophage® XR, Glumetza®
Metformin, 500 mg or 850 mg oral tablets, twice or three times a day (BID or TID) for a total dose of at least 1500 mg daily; administered with food.
SitagliptinDrug
Also called Januvia®, Tesavel®, Xelevia®, Ristaben®
Sitagliptin, 100 mg oral tablet, once daily (QD); administered with or without food
AcarboseDrug
Also called Precose®, Glucobay™
Acarbose, 50 mg oral tablets, TID (150 mg total daily dose); administered with the first bite of each main meal.
RepaglinideDrug
Also called Prandin®, Fulaidi™
Repaglinide, 0.5 mg and/or 1 mg oral tablets, TID (up to 16 mg daily); administered within 30 minutes of each meal.
GlimepirideDrug
Also called Amaryl®, Glimy
Glimepiride, 1 mg and/or 2 mg oral tablets, QD (up to 6 mg daily); administered before the first main meal of the day
GliclazideDrug
Also called Diamicron MR™
Gliclazide, 30 mg oral tablets, QD or BID (30 mg to 120 mg total daily dose); administered with meal.

Study groups in NCT01709305
Study group	Role	What they receive
Metformin + Sitagliptin + Glimepiride	Active comparator	During Phase 2, participants receive up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). Receives: Drug: Metformin; Drug: Sitagliptin; Drug: Glimepiride
Metformin + Sitagliptin + Repaglinide	Experimental	During Phase 2, participants receive up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). Receives: Drug: Metformin; Drug: Sitagliptin; Drug: Repaglinide
Metformin + Sitagliptin + Acarbose	Experimental	During Phase 2, participants receive 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). Receives: Drug: Metformin; Drug: Sitagliptin; Drug: Acarbose
Metformin + Sitagliptin + Gliclazide	Experimental	During Phase 2, participants receive 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). Receives: Drug: Metformin; Drug: Sitagliptin; Drug: Gliclazide

What is being measured

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

Change From Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2)
HbA1c is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change from baseline reflects the Week 44 A1C minus baseline A1C. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used. Change from baseline was based on the constrained longitudinal data analysis (cLDA) model including all available measurements from baseline through the last visit. The terms in the cLDA model include treatment, time in weeks (categorical), regions, and treatment-by-time interaction.
Measured: Phase 2 Baseline (Week 20) and Week 44

Secondary outcomes (6)

Change From Phase 2 Baseline to Week 44 in Participant Body Weight (Phase 2)
Change from baseline in body weight in Phase 2 was reported. Change from baseline reflects the Week 44 body weight minus baseline body weight. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used.
Measured: Phase 2 Baseline (Week 20), Week 44
Percentage of Participants With Hypoglycemia Events (Phase 2)
Hypoglycemia events represent epidsodes symptomatic of hypoglycemia (e.g., weakness, dizziness, shakiness, increased sweating, palpitations, or confusion) and/or finger stick glucose values of ≤70 mg/dL (3.9 mmol/L). The percentage of participants with hypoglycemia events was reported.
Measured: From Week 20 through Week 44
Percentage of Participants With a Gastrointestinal (GI) AE of Nausea (Phase 2)
The percentage of participants with a GI AE of "nausea" was reported.
Measured: From Week 20 through Week 44
Percentage of Participants With a GI AE of Vomiting (Phase 2)
The percentage of participants with a GI AE of "vomiting" was reported.
Measured: From Week 20 through Week 44
Percentage of Participants With a GI AE of Diarrhea (Phase 2)
The percentage of participants with a GI AE of "diarrhea" was reported.
Measured: From Week 20 through Week 44
Percentage of Participants With a GI AE of Abdominal Pain (Phase 2)
The percentage of participants with a GI AE of "abdominal pain" was reported.
Measured: From Week 20 through Week 44

Timeline

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

8 Nov 201217 Apr 2015

First posted18 Oct 2012 (estimated)
Study start8 Nov 2012
Primary completion17 Apr 2015
Study completion17 Apr 2015

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 (1)Papers the sponsor has linked to this study.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 5,570 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01709305
Sponsor's protocol ID: 0431-313
Status last verified: Jul 2018
First submitted: 16 Oct 2012
Last updated: 21 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Xu W, Mu Y, Zhao J, Zhu D, Ji Q, Zhou Z, Yao B, Mao A, Engel SS, Zhao B, Bi Y, Zeng L, Ran X, Lu J, Ji L, Yang W, Jia W, Weng J. Efficacy and safety of metformin and sitagliptin based triple antihyperglycemic therapy (STRATEGY): a multicenter, randomized, controlled, non-inferiority clinical trial. Sci China Life Sci. 2017 Mar;60(3):225-238. doi: 10.1007/s11427-016-0409-7. Epub 2017 Feb 7.
PubMed 28271251

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 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Active-Controlled, Open-label Clinical Trial to Evaluate the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose as a Third OAHA on Top of Sitagliptin+Metformin Combination Therapy in Chinese Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01709305
Acronym / sponsor ID: 0431-313
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 5,570 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 8 Nov 2012 (actual)
Primary completion: 17 Apr 2015 (actual)
Study completion: 17 Apr 2015 (actual)
First posted: 18 Oct 2012 (estimated)
Results: Posted 11 May 2016

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Metformin + Sitagliptin + Glimepiride	Active comparator	Drug: Metformin, Drug: Sitagliptin, Drug: GlimepirideDuring Phase 2, participants receive up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
Metformin + Sitagliptin + Repaglinide	Experimental	Drug: Metformin, Drug: Sitagliptin, Drug: RepaglinideDuring Phase 2, participants receive up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
Metformin + Sitagliptin + Acarbose	Experimental	Drug: Metformin, Drug: Sitagliptin, Drug: AcarboseDuring Phase 2, participants receive 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
Metformin + Sitagliptin + Gliclazide	Experimental	Drug: Metformin, Drug: Sitagliptin, Drug: GliclazideDuring Phase 2, participants receive 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).

Who may qualify

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

Key inclusion criteria (2 listed)

Has Type 2 Diabetes Mellitus;
Agrees to use an effective method of contraception or must not otherwise be at risk of becoming pregnant (female participants).

Key exclusion criteria (14 listed)

Has a history of type 1 diabetes mellitus or a history of ketoacidosis;
Has been treated with insulin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a Glucagon-like peptide-1 (GLP-1) mimetic or analogue before;
Is on a weight loss program (not in maintenance phase), has started a weight loss medication, or has undergone bariatric surgery within 12 months;
Has undergone a surgical procedure within 4 weeks;
Has had new or worsening signs or symptoms of coronary heart disease or congestive heart failure within past 3 months, or has acute coronary syndrome, coronary artery intervention, or stroke or transient ischemic neurological disorder;

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
MetforminAlso: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®Metformin, 500 mg or 850 mg oral tablets, twice or three times a day (BID or TID) for a total dose of at least 1500 mg daily; administered with food.	Drug	Metformin + Sitagliptin + Acarbose, Metformin + Sitagliptin + Gliclazide, Metformin + Sitagliptin + Glimepiride, Metformin + Sitagliptin + Repaglinide
SitagliptinAlso: Januvia®, Tesavel®, Xelevia®, Ristaben®Sitagliptin, 100 mg oral tablet, once daily (QD); administered with or without food	Drug	Metformin + Sitagliptin + Acarbose, Metformin + Sitagliptin + Gliclazide, Metformin + Sitagliptin + Glimepiride, Metformin + Sitagliptin + Repaglinide
AcarboseAlso: Precose®, Glucobay™Acarbose, 50 mg oral tablets, TID (150 mg total daily dose); administered with the first bite of each main meal.	Drug	Metformin + Sitagliptin + Acarbose
RepaglinideAlso: Prandin®, Fulaidi™Repaglinide, 0.5 mg and/or 1 mg oral tablets, TID (up to 16 mg daily); administered within 30 minutes of each meal.	Drug	Metformin + Sitagliptin + Repaglinide
GlimepirideAlso: Amaryl®, GlimyGlimepiride, 1 mg and/or 2 mg oral tablets, QD (up to 6 mg daily); administered before the first main meal of the day	Drug	Metformin + Sitagliptin + Glimepiride
GliclazideAlso: Diamicron MR™Gliclazide, 30 mg oral tablets, QD or BID (30 mg to 120 mg total daily dose); administered with meal.	Drug	Metformin + Sitagliptin + Gliclazide

Primary outcome

Change From Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2)
Time frame: Phase 2 Baseline (Week 20) and Week 44
HbA1c is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change from baseline reflects the Week 44 A1C minus baseline A1C. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used. Change from baseline was based on the constrained longitudinal data analysis (cLDA) model including all available measurements from baseline through the last visit. The terms in the cLDA model include treatment, time in weeks (categorical), regions, and treatment-by-time interaction.

6 secondary outcomes

Change From Phase 2 Baseline to Week 44 in Participant Body Weight (Phase 2)
Time frame: Phase 2 Baseline (Week 20), Week 44
Percentage of Participants With Hypoglycemia Events (Phase 2)
Time frame: From Week 20 through Week 44
Percentage of Participants With a Gastrointestinal (GI) AE of Nausea (Phase 2)
Time frame: From Week 20 through Week 44
Percentage of Participants With a GI AE of Vomiting (Phase 2)
Time frame: From Week 20 through Week 44
Percentage of Participants With a GI AE of Diarrhea (Phase 2)
Time frame: From Week 20 through Week 44
Percentage of Participants With a GI AE of Abdominal Pain (Phase 2)
Time frame: From Week 20 through Week 44

Results and safety

Results posted to the registry on 11 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1: Sitagliptin + Metformin	5,570	4,933
Phase 2: Metformin + Sitagliptin + Glimepiride	0	0
Phase 2: Metformin + Sitagliptin + Repaglinide	0	0
Phase 2: Metformin + Sitagliptin + Acarbose	0	0
Phase 2: Metformin + Sitagliptin + Gliclazide	0	0

Primary outcome: Change From Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2)

Time frame: Phase 2 Baseline (Week 20) and Week 44. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Phase 2: Metformin + Sitagliptin + Glimepiride n = 414	Phase 2: Metformin + Sitagliptin + Repaglinide n = 418	Phase 2: Metformin + Sitagliptin + Acarbose n = 472	Phase 2: Metformin + Sitagliptin + Gliclazide n = 418
Value	-0.65 (0.84)	-0.62 (0.84)	-0.46 (0.83)	-0.69 (0.90)

Phase 2: Metformin + Sitagliptin + Glimepiride vs Phase 2: Metformin + Sitagliptin + Acarbose: Difference in LS Means: 0.19 (98.34% CI 0.02 to 0.36)
Phase 2: Metformin + Sitagliptin + Glimepiride vs Phase 2: Metformin + Sitagliptin + Repaglinide: Difference in LS Means: 0.03 (98.34% CI -0.15 to 0.21)
Phase 2: Metformin + Sitagliptin + Glimepiride vs Phase 2: Metformin + Sitagliptin + Gliclazide: Difference in LS Means: -0.05 (98.34% CI -0.23 to 0.14)

Population analysed: Per-Protocol (PP) population - excluded those participants who were identified as protocol violators and those who were non-compliant with Good Clinical Practice (GCP) requirements.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 46 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1: Sitagliptin + Metformin	63 of 5,527 (1.1%)	66 of 5,527 (1.2%)	Not reported
Phase 2: Metformin + Sitagliptin + Acarbose	11 of 551 (2%)	3 of 551 (0.5%)	Not reported
Phase 2: Metformin + Sitagliptin + Repaglinide	9 of 545 (1.7%)	33 of 545 (6.1%)	Not reported
Phase 2: Metformin + Sitagliptin + Gliclazide	10 of 550 (1.8%)	20 of 550 (3.6%)	Not reported
Phase 2: Metformin + Sitagliptin + Glimepiride	8 of 549 (1.5%)	48 of 549 (8.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28271251Xu W, Mu Y, Zhao J, Zhu D, Ji Q, Zhou Z, Yao B, Mao A, Engel SS, Zhao B, Bi Y, Zeng L, Ran X, Lu J, Ji L, Yang W, Jia W, Weng J. Efficacy and safety of metformin and sitagliptin based triple antihyperglycemic therapy (STRATEGY): a multicenter, randomized, controlled, non-inferiority clinical trial. Sci China Life Sci. 2017 Mar;60(3):225-238. doi: 10.1007/s11427-016-0409-7. Epub 2017 Feb 7.
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 4 study testing Metformin, Sitagliptin and Acarbose in people with Type 2 Diabetes Mellitus, 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 2 inclusion and 14 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 21 Aug 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 May 2016). 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 Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2) (time frame: Phase 2 Baseline (Week 20) and Week 44). 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 NCT01709305, which also lists 1 linked publication.

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 Aug 2018.