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Diabetes Mellitus, Type 2Phase 3CLMF237A1303NCT01811485

Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy

A Phase 3 study testing LMF237 50/250 mg and LMF237 50/500 mg in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 30 sites in Japan.

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

The purpose of the study was to evaluate the efficacy and safety of LMF237 50/250 mg and 50/500 mg bid in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy. Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
LMF237 50/250 mg and LMF237 50/500 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
171 participants
Where
30 sitesJapan
Study dates
May 2013to Feb 2014
Phase
Phase 3
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 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy
  • HbA1c in the range of 7.0-10.0%
  • Body mass index in the range of 20-35 kg/m^2

Who cannot join

  • Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
  • Significant heart diseases Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Japan30 sites

  • Novartis Investigative Site

    Ageo, Saitama, 362-8588

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-0031

  • Novartis Investigative Site

    Chikushino-shi, Fukuoka, 818-0083

  • Novartis Investigative Site

    Edogawa-ku, Tokyo, 134-0084

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 810-0014

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 819-0006

  • Novartis Investigative Site

    Hachiōji, Tokyo, 192-0046

  • Novartis Investigative Site

    Hachiōji, Tokyo, 192-0918

  • Novartis Investigative Site

    Iizuka, Fukuoka, 820-8505

  • Novartis Investigative Site

    Katsushika-ku, Tokyo, 124-0024

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 210-0852

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 800-0296

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 807-0857

  • Novartis Investigative Site

    Kiyose, Tokyo, 204-0021

  • Novartis Investigative Site

    Koga, Ibaraki, 306-0232

  • Novartis Investigative Site

    Kyoto, Kyoto, 607-8062

  • Novartis Investigative Site

    Kyoto, Kyoto, 615-0035

  • Novartis Investigative Site

    Minato-ku, Tokyo, 105-7390

  • Novartis Investigative Site

    Minato-ku, Tokyo, 108-0075

  • Novartis Investigative Site

    Nerima-ku, Tokyo, 177-0051

  • Novartis Investigative Site

    Sakai, Osaka, 590-0064

  • Novartis Investigative Site

    Shibuya-ku, Tokyo, 150-0002

  • Novartis Investigative Site

    Shinagawa-ku, Tokyo, 141-0032

  • Novartis Investigative Site

    Takatsuki, Osaka, 569-1096

  • Novartis Investigative Site

    Tokorozawa, Saitama, 359-1161

  • Novartis Investigative Site

    Toshima-ku, Tokyo, 171-0021

  • Novartis Investigative Site

    Yatsushiro, Kumamoto, 866-8533

  • Novartis Investigative Site

    Yatsushiro, Kumamoto, 866-8660

  • Novartis Investigative Site

    Yokohama, Kanagawa, 221-0802

  • Novartis Investigative Site

    Yokohama, Kanagawa, 231-0023

Other trials in Japan

About this study

Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 14 Weeks Treatment With LMF237 Bid to Placebo in Patients With Type 2 Diabetes Inadequately Controlled With Vildagliptin 50 mg Bid Monotherapy

The purpose of the study was to evaluate the efficacy and safety of LMF237 50/250 mg and 50/500 mg bid in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy. This study was conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of T2DM in Japan.

Being tested
LMF237 50/250 mg, LMF237 50/500 mg, 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.

  • LMF237 50/250 mgDrug

    Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily

  • LMF237 50/500 mgDrug

    Corresponds to vildagliptin 50 mg twice daily and metformin 500 mg twice daily

  • PlaceboDrug

    Matching placebo of LMF237 (contained vildagliptin 50 mg as active ingredient) twice daily

Study groups in NCT01811485
Study groupRoleWhat they receive
LMF237 50/250 mgExperimentalPatients took LMF237 50/250 mg twice daily for 14 weeks
Receives: Drug: LMF237 50/250 mg; Drug: LMF237 50/500 mg
LMF237 50/500 mgExperimentalPatients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
Receives: Drug: LMF237 50/250 mg
PlaceboPlacebo comparatorPatients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 14 Weeks Between Treatment Groups

    HbA1c was performed on a blood sample obtained and measured by High performance liquid chromatography (HPLC). HPCL was performed at a central laboratory.

    Measured: Baseline to 14 weeks

Secondary outcomes (4)

  1. Change From Baseline in HbA1c at 14 Weeks Within LMF237 Treatment Groups

    HbA1c will be performed on a blood sample obtained and measured by HPLC. HPCL was performed at a central laboratory.

    Measured: Baseline to 14 weeks

  2. Percentage of Patients Meeting Responder Rates in HbA1c

    Responder rate was analyzed in categories: 1. Endpoint HbA1c ≤ 6.5% 2. Endpoint HbA1c < 7% 3. Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8% 4. Endpoint HbA1c < 6.9% 5. HbA1c reduction from baseline at endpoint ≥ 1% 6. HbA1c reduction from baseline at endpoint ≥ 0.5%.

    Categories 1, 2, and 4 - 'n' includes only patients with baseline HbA1c > 6.5%, ≥ 7%, ≥ 6.9% and endpoint HbA1c measurement. Category 3, 'n' includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c. Category 5 and 6, 'n' indicates number of patients with both baseline and endpoint HbA1c measurements.

    Measured: Baseline, 14 weeks

  3. Change From Baseline in Fasting Plasma Glucose (FPG) at 14 Weeks

    FPG was performed on a blood sample obtained and analyzed at a central laboratory.

    Measured: Baseline to 14 weeks

  4. Number of Patients With Adverse Events (Including Hypoglycemia), Serious Adverse Events and Death

    The occurrence of adverse events were sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

    Measured: 14 weeks

Timeline

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

  1. First posted14 Mar 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01811485
Sponsor's protocol ID
CLMF237A1303
Acronym
CLMF237A1303
Status last verified
Feb 2015
First submitted
12 Mar 2013
Last updated
23 Feb 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LMF237 50/250 mg and LMF237 50/500 mg in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 30 sites in Japan.

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 2 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 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Japan. 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. 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 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?

Yes. Results are posted in the registry (first posted 23 Feb 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?

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 14 Weeks Between Treatment Groups (time frame: Baseline to 14 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 NCT01811485.

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 23 Feb 2015.

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