Type 2 Diabetes MellitusPhase 4VARIABLENCT01910441

Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients

A Phase 4 study testing Vildagliptin, Glimepiride and Metformin in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals.

Terminated

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

Official record

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Trial summary

Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on glucose variability in T2DM patients. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Vildagliptin, Glimepiride and Metformin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 95 participants
Where: No sites listed yet
Study dates: Jul 2013to Sep 2014
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

Patients who have given written informed consent to participate in the study.
Type 2 Diabetes Mellitus patients either Male or female from 18 - 75 years of age (both inclusive).
Patients who are uncontrolled on metformin monotherapy for at least past 4 weeks (1000-1500 mg daily and HbA1c > 7.5 - 9%).
Patients with HbA1C levels within the range > 7.5% - 9%. (If a past value is available within the last 12 weeks, it would be considered acceptable provided it was obtained after at least 4 weeks of metformin therapy 1000-1500 mg daily).

Who cannot join

Age > 75 years ; BMI <22 or >40 kg/m2
Patients who are on Insulin therapy at the time of study entry.
Type 1 Diabetes Mellitus patients.
Patients with severe renal (creatinine clearance < 50 ml/min) or hepatic impairment (including pre-treatment ALT or AST > 3 x ULN).
Creatinine clearance will be estimated from serum creatinine using Cockcroft-Gault formula (Cockcroft and Gault, 1976)
Patients with contraindications as mentioned in the Summary of Product Characteristics (SPCs) for vildagliptin, metformin, glimepiride, vildagliptin plus metformin and glimiperide plus metformin.
Other protocol defined inclusion/exclusion criteria may apply.

About this study

Official title: A Comparative Study to Assess the Effect of Vildagliptin Versus Glimepiride on Glucose Variability in Type 2 Diabetic Patients Uncontrolled on Metformin Alone

Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on glucose variability in T2DM patients.

Conditions: Type 2 Diabetes Mellitus
Being tested: Vildagliptin, Glimepiride, Metformin
Keywords: Type 2 Diabetes Mellitus, Glycemic variability
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
Vildagliptin 50 mg twice daily
GlimepirideDrug
Glimepiride 1-6 mg once daily
MetforminDrug
Metformin (1000-1500 mg daily)

Study groups in NCT01910441
Study group	Role	What they receive
Group A: Vildagliptin plus metformin	Experimental	Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily). Receives: Drug: Vildagliptin; Drug: Metformin
Group B: Glimepiride plus metformin	Active comparator	Participants received Glimepiride 1-6 mg once daily as an add-on to metformin (1000-1500mg daily). Receives: Drug: Glimepiride; Drug: Metformin

What is being measured

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

Mean Amplitude of Glycemic Excursions (MAGE)
Measured: 16 weeks

Timeline

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

Jul 2013Sep 2014

First posted29 Jul 2013 (estimated)
Study startJul 2013
Primary completionSep 2014
Study completionSep 2014

Why it stopped: The study was terminated due to the unavailability of Continuous Glucose Monitoring sensors (CGMS) which were required to assess the primary end-point.

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 Novartis PharmaceuticalsThe 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: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01910441
Sponsor's protocol ID: CLAF237AIN03
Acronym: VARIABLE
Status last verified: Sep 2015
First submitted: 25 Jul 2013
Last updated: 28 Oct 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 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparative Study to Assess the Effect of Vildagliptin Versus Glimepiride on Glucose Variability in Type 2 Diabetic Patients Uncontrolled on Metformin Alone
ClinicalTrials.gov ID: NCT01910441
Acronym / sponsor ID: VARIABLE / CLAF237AIN03
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, Glycemic variability
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated due to the unavailability of Continuous Glucose Monitoring sensors (CGMS) which were required to assess the primary end-point.
Enrolment: 95 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 29 Jul 2013 (estimated)
Results: Posted 28 Oct 2015

Clinical summary

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

Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on glucose variability in T2DM patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A: Vildagliptin plus metformin	Experimental	Drug: Vildagliptin, Drug: MetforminParticipants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
Group B: Glimepiride plus metformin	Active comparator	Drug: Glimepiride, Drug: MetforminParticipants received Glimepiride 1-6 mg once daily as an add-on to metformin (1000-1500mg daily).

Who may qualify

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

Key inclusion criteria (4 listed)

Patients who have given written informed consent to participate in the study.
Type 2 Diabetes Mellitus patients either Male or female from 18 - 75 years of age (both inclusive).
Patients who are uncontrolled on metformin monotherapy for at least past 4 weeks (1000-1500 mg daily and HbA1c > 7.5 - 9%).
Patients with HbA1C levels within the range > 7.5% - 9%. (If a past value is available within the last 12 weeks, it would be considered acceptable provided it was obtained after at least 4 weeks of metformin therapy 1000-1500 mg daily).

Key exclusion criteria (7 listed)

Age > 75 years ; BMI <22 or >40 kg/m2
Patients who are on Insulin therapy at the time of study entry.
Type 1 Diabetes Mellitus patients.
Patients with severe renal (creatinine clearance < 50 ml/min) or hepatic impairment (including pre-treatment ALT or AST > 3 x ULN).
Creatinine clearance will be estimated from serum creatinine using Cockcroft-Gault formula (Cockcroft and Gault, 1976)

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
VildagliptinVildagliptin 50 mg twice daily	Drug	Group A: Vildagliptin plus metformin
GlimepirideGlimepiride 1-6 mg once daily	Drug	Group B: Glimepiride plus metformin
MetforminMetformin (1000-1500 mg daily)	Drug	Group A: Vildagliptin plus metformin, Group B: Glimepiride plus metformin

Primary outcome

Mean Amplitude of Glycemic Excursions (MAGE)
Time frame: 16 weeks

Results and safety

Results posted to the registry on 28 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: Vildagliptin Plus Metformin	48	41
Group B: Glimepiride Plus Metformin	47	37

Primary outcome: Mean Amplitude of Glycemic Excursions (MAGE)

Time frame: 16 weeks

Population analysed: The study was prematurely terminated due to the unavailability of CGMS required for the assessment of the primary end point. The non-availability of CGMS severely affected participant recruitment. The primary outcome was not analyzed.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A: Vildagliptin Plus Metformin	0 of 48 (0%)	4 of 48 (8.3%)	Not reported
Group B: Glimepiride Plus Metformin	1 of 47 (2.1%)	1 of 47 (2.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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
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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.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vildagliptin, Glimepiride and Metformin in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals.

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 4 inclusion and 7 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 28 Oct 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 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 28 Oct 2015). 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?

Mean Amplitude of Glycemic Excursions (MAGE) (time frame: 16 weeks). 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 NCT01910441.

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 28 Oct 2015.