Type 2 Diabetes MellitusPhase 1NCT01537120

Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)

A Phase 1 study testing Vildagliptin 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 79 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Vildagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: No sites listed yet
Study dates: Dec 2011to Oct 2012
Phase: Phase 1
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 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of type 2 diabetes mellitus on a clinical regimen that is metformin alone, up to a maximum of 3 gram per day, on a background of lifestyle measures, and has a Hemoglobin A1C at screening of > 7%.
If on antihyperglycemic therapy with both metformin and sulfonylurea with a Screening Visit/Visit 1 Hemoglobin A1C of >= 6.5% and =< 7.5%, should then discontinue sulfonylurea usage and undergo washout of sulfonylurea.

Who cannot join

History of either stroke, chronic seizures or major neurological disorder within the last 6 months.
Untreated hypertension with a blood pressure of > 160/95 mmHg.
History of neoplastic disease within the past 5 years.
History of hypersensitivity to vildagliptin or other DPP4 inhibitors.
Had major surgery, or donated or lost 1 unit (500 mL) of blood, or participated in another investigational study within 4 weeks prior to screen.
Used any illicit drug or abusively used alcohol within the past 3 months.

About this study

Official title: Evaluation of Continuous Glucose Monitoring as a Tool to Measure Glucoregulatory Effects of a Twice Daily Oral Insulin Secretagogue

This trial will attempt to develop the use of Continuous Glucose Monitoring (CGM) as a tool for the evaluation of both new and existing pharmacological treatments for type 2 diabetes, using the twice daily administered dipeptidyl peptidase-4 (DPP4) inhibitor, vildagliptin as a probe. The primary hypothesis is that two weeks of treatment with 50 mg of oral Vildagliptin, twice daily will lead to a statistically significant decrease in 24 hour weighted-mean glucose (WMG) relative to placebo.

Conditions: Type 2 Diabetes Mellitus
Being tested: Vildagliptin, Placebo
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.

VildagliptinDrug
PlaceboDrug

Study groups in NCT01537120
Study group	Role	What they receive
Placebo → Vildagliptin	Experimental	Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily Receives: Drug: Vildagliptin; Drug: Placebo

What is being measured

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

24 Hour Weighted Mean Glucose (WMG) At 2 Weeks
The 24 hour WMG was measured after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment. Glucose was measured over a 24 hour period by having participants wear two continuous glucose monitors (CGM), which produced an average glucose value approximately every 5 minutes. Using these values, the concentration of glucose was calculated from Area Under the Curve 0-24 hours (AUC 0-24hr), and was expressed as 24 hour WMG.
Measured: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment

Secondary outcomes (2)

Hemoglobin A1C (HbA1C) At 2 Weeks
Blood samples were taken after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%).
Measured: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment
HbA1C At 12 Weeks
Blood samples were taken after 2 weeks of placebo treatment, and again after 12 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%).
Measured: At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment

Timeline

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

Dec 2011Oct 2012

First posted23 Feb 2012 (estimated)
Study startDec 2011
Primary completionOct 2012
Study completionOct 2012

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 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01537120
Sponsor's protocol ID: 0000-258
Status last verified: Aug 2015
First submitted: 22 Dec 2011
Last updated: 19 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

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 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Continuous Glucose Monitoring as a Tool to Measure Glucoregulatory Effects of a Twice Daily Oral Insulin Secretagogue
ClinicalTrials.gov ID: NCT01537120
Acronym / sponsor ID: 0000-258
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 23 Feb 2012 (estimated)
Results: Posted 3 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: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 1

Arm	Type	Receives
Placebo → Vildagliptin	Experimental	Drug: Vildagliptin, Drug: PlaceboParticipants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Clinical diagnosis of type 2 diabetes mellitus on a clinical regimen that is metformin alone, up to a maximum of 3 gram per day, on a background of lifestyle measures, and has a Hemoglobin A1C at screening of > 7%.
If on antihyperglycemic therapy with both metformin and sulfonylurea with a Screening Visit/Visit 1 Hemoglobin A1C of >= 6.5% and =< 7.5%, should then discontinue sulfonylurea usage and undergo washout of sulfonylurea.

Key exclusion criteria (6 listed)

History of either stroke, chronic seizures or major neurological disorder within the last 6 months.
Untreated hypertension with a blood pressure of > 160/95 mmHg.
History of neoplastic disease within the past 5 years.
History of hypersensitivity to vildagliptin or other DPP4 inhibitors.
Had major surgery, or donated or lost 1 unit (500 mL) of blood, or participated in another investigational study within 4 weeks prior to screen.

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
Vildagliptin	Drug	Placebo → Vildagliptin
Placebo	Drug	Placebo → Vildagliptin

Primary outcome

24 Hour Weighted Mean Glucose (WMG) At 2 Weeks
Time frame: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment
The 24 hour WMG was measured after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment. Glucose was measured over a 24 hour period by having participants wear two continuous glucose monitors (CGM), which produced an average glucose value approximately every 5 minutes. Using these values, the concentration of glucose was calculated from Area Under the Curve 0-24 hours (AUC 0-24hr), and was expressed as 24 hour WMG.

2 secondary outcomes

Hemoglobin A1C (HbA1C) At 2 Weeks
Time frame: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment
HbA1C At 12 Weeks
Time frame: At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment

Results and safety

Results posted to the registry on 3 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
Placebo → Vildagliptin	25	25

Primary outcome: 24 Hour Weighted Mean Glucose (WMG) At 2 Weeks

Time frame: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment. Geometric mean (Geometric Coefficient of Variation). Unit: mg/dL

Measure	Placebo n = 24	Vildagliptin n = 23
Value	126.9 (16)	114.2 (17)

Placebo vs Vildagliptin: Geometric Mean Ratio: 0.91 (90% CI 0.85 to 0.96)

Population analysed: Per-Protocol Population: all participants who complied with the assigned medication during each period of study.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vildagliptin 50 mg	0 of 23 (0%)	8 of 23 (34.8%)	Not reported
Placebo	0 of 24 (0%)	6 of 24 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruitingPhase 3
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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vildagliptin 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 6 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 19 Aug 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 3 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?

24 Hour Weighted Mean Glucose (WMG) At 2 Weeks (time frame: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment). 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 NCT01537120.

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 19 Aug 2015.