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Type 2 Diabetes MellitusPhase 3NCT02343926

Phase 3 Study to Compare the Efficacy and Safety of Gemigliptin and Vildagliptin as Add-on Therapy to Metformin in People With Type 2 Diabetes Inadequately Controlled With Metformin

A Phase 3 study testing GEMIGLIPTIN LS15-0444, vildagliptin and metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in Russia.

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

Primary Objective: To compare the clinical efficacy of gemigliptin and vildagliptin as add-on therapy to metformin in terms of change in Hemoglobin A1c (HbA1c) reduction. Secondary Objectives: To compare the safety and tolerability of gemigliptin and vildagliptin: Number of patients who experience at least one episode… 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?
GEMIGLIPTIN LS15-0444, vildagliptin and metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
443 participants
Where
1 siteRussia
Study dates
Dec 2014to Apr 2016
Phase
Phase 3
Are there results?
None posted in the registry

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 with Type 2 diabetes mellitus.
  • Patients inadequately controlled with metformin at the maximal effective and tolerated dose of metformin for at least 12 weeks or who are on a stable dose of ≥1500 mg daily for a minimum of ≥4 weeks prior to study entry.
  • Signed informed consent obtained prior to any study procedures.

Who cannot join

  • Patients with type 1 diabetes mellitus, gestational diabetes, or diabetes secondary to pancreatic disorders, drug or chemical agent intake.
  • Male and female younger than 18 and older than 75 years old.
  • Patients with HbA1c ≤7% and ≥9.5%.
  • Patients with 20 kg/m^2 > body mass index (BMI) >40 kg/m^2.
  • Patients with history of hypersensitivity to metformin.
  • Patients with history of hypersensitivity to vildagliptin.
Show all 24Show fewer
  • Lactose intolerance, lactase deficit, glucose-galactose malabsorption.
  • Patients who have a history of acute metabolic complications such as lactic acidosis, diabetic pre-coma, diabetic ketoacidosis or hyperosmolar hyperglycemic state within 3 months before study entry.
  • Patients who were treated with insulin or glucagon-like peptide-1 (GLP-1) analogue.
  • Patients who have been treated by thiazolidinediones (pioglitazone) in the last 6 months.
  • Use of systemic glucocorticosteroids (excluding topical application or inhaled forms) for 7 consecutive days or within more than 3 months prior to study entry.
  • Patients with impaired hepatic function (alanine transaminase [ALT], aspartate transaminase [AST] activity >1.5 times the upper limit of normal [ULN]).
  • Patients with impaired renal function (serum creatinine concentration >135ɥmol/l in men and >110ɥmol/l in female).
  • Patients who had experienced myocardial infarction, stroke, unstable angina or coronary artery bypass surgery within 6 months prior to screening, or patients with arrhythmia requiring treatment.
  • Patients with chronic heart failure II-IV functional class according to the classification of NYHA (New York Heart Association).
  • Patients taking medicines of thyroid hormones, warfarin, dicoumarin or digoxin.
  • Patients who took sodium channel blockers and SGLT2 inhibitors (or inhibitors sodium glucose transporters 2) in the last 6 weeks prior to study entry.
  • Known history of alcohol or drug abuse within 6 months prior to screening.
  • Pregnant or woman during breast feeding period.
  • Women of childbearing potential not protected by effective contraceptive method of birth control.
  • Men whose partners are planning pregnancy.
  • History of hypersensitivity to the study drug or to a drug with a similar chemical structure.
  • Use of any investigational drug within 3 months prior to study entry.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Investigational Site 03

    Vladimir, Vladimirskaya Oblast’, 600023

Other trials in Russia

About this study

Official title: A Multicentre, National, Randomized, Parallel-group, Phase 3 Study to Compare the Efficacy and Safety of Gemigliptin and Vildagliptin as Add-on Therapy to Metformin in People With Type 2 Diabetes Inadequately Controlled With Metformin

Primary Objective:

To compare the clinical efficacy of gemigliptin and vildagliptin as add-on therapy to metformin in terms of change in Hemoglobin A1c (HbA1c) reduction.

Secondary Objectives:

To compare the safety and tolerability of gemigliptin and vildagliptin:

  • Number of patients who experience at least one episode of hypoglycemia.
  • Number of patients experiencing adverse event (AE), serious adverse event (SAE).
  • Assessment of patients compliance defined as number tablets returned by patients.
Read the detailed description

The study consists of 2 weeks screening and 24 weeks of treatment (a total of 26 weeks).

The protocol includes a screening period of two weeks, after which they will be randomized to receive gemigliptin or vildagliptin.

Patients will be evaluated through 4 mandatory visits during the study. Visit 1: Week -2 (screening) Visit 2: Week 0 (randomization) Visit 3: Week 12 (efficacy and safety evaluation) Visit 4: Week 24 (efficacy and safety evaluation)

Being tested
GEMIGLIPTIN LS15-0444, vildagliptin, metformin
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.

  • GEMIGLIPTIN LS15-0444Drug

    Also called Zemiglo

    Pharmaceutical form:tablet

    Route of administration: oral

  • vildagliptinDrug

    Also called Galvus

    Pharmaceutical form:tablet

    Route of administration: oral

  • metforminDrug

    Pharmaceutical form:tablet

    Route of administration: oral

Study groups in NCT02343926
Study groupRoleWhat they receive
GemigliptinExperimentalGEMIGLIPTIN LS15-0444 administered once a day for 24 weeks as add-on therapy to metformin
Receives: Drug: GEMIGLIPTIN LS15-0444; Drug: metformin
VildagliptinActive comparatorVildagliptin administered twice a day for 24 weeks as add-on therapy to metformin
Receives: Drug: vildagliptin; Drug: metformin

What is being measured

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

  1. Change from baseline in HbA1c

    Measured: Up to Week 24

Secondary outcomes (8)

  1. Change from baseline in fasting plasma glucose

    Measured: Up to Week 24

  2. Change from baseline in postprandial glucose

    Measured: Up to Week 24

  3. Percentage of patients achieving HbA1c <7% and <6.5%

    Measured: Up to Week 24

  4. Percentage of patients with at least one episode of hypoglycemia

    Measured: Up to Week 24

  5. Number of episode of hypoglycemia (symptomatic, asymptomatic, severe hypoglycemia)

    Measured: Up to Week 24

  6. Change from baseline in body weight

    Measured: Up to Week 24

  7. Number of adverse events

    Measured: Up to Week 24

  8. Number of serious adverse events

    Measured: Up to Week 24

Timeline

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

  1. First posted22 Jan 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
443 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02343926
Sponsor's protocol ID
GEMIGL07185
Other IDs
U1111-1165-9138
Status last verified
May 2016
First submitted
16 Jan 2015
Last updated
18 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GEMIGLIPTIN LS15-0444, vildagliptin and metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in Russia.

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 3 inclusion and 24 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 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 HbA1c (time frame: Up to Week 24). 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 NCT02343926.

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 18 May 2016.

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