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Type 2 Diabetes Mellitus (T2DM)Phase 4NCT02002221

Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients

A Phase 4 study testing Vildagliptin (LAF237), Insulin and Metformin in people with Type 2 Diabetes Mellitus (T2DM), run by Novartis Pharmaceuticals at 31 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 this study was to assess the efficacy and safety of vildagliptin 50 mg bid add-on therapy to improve overall glycemic control in patients with T2DM inadequately controlled by insulin, with or without concomitant metformin treatment. Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM)
What is being tested?
Vildagliptin (LAF237), Insulin and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
156 participants
Where
31 sitesJapan
Study dates
Dec 2013to Feb 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 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of T2DM by standard criteria.
  • HbA1c ≥ 7.0 to ≤ 10% at Visit 1.
  • Age: ≥ 20 to < 75 years old at Visit 1.
  • BMI ≥ 20 to ≤ 35 kg/m2 at Visit 1.

Who cannot join

  • FPG ≥ 270 mg/dL (≥15 mmol/L) at Visit 1.
  • Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
  • Significant heart diseases
  • Hepatic disorder
  • Other protocol defined inclusion/exclusion criteria may apply

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

Japan31 sites

  • Novartis Investigative Site

    Adachi-ku, Tokyo, 123-0845

  • Novartis Investigative Site

    Ageo, Saitama, 362-8588

  • Novartis Investigative Site

    Chiyoda-ku, Tokyo, 101-0024

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 103-0027

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 103-0028

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 104-0061

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 810-8798

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 815-0071

  • Novartis Investigative Site

    Fukutsu, Fukuoka, 811-3217

  • Novartis Investigative Site

    Hirakata, Osaka, 573-0153

  • Novartis Investigative Site

    Ibusuki, Kagoshima-ken, 891-0401

  • Novartis Investigative Site

    Izumisano, Osaka, 598-8577

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 800-0295

  • Novartis Investigative Site

    Kōriyama, Fukushima, 963-8851

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 861-8039

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 861-8520

  • Novartis Investigative Site

    Kyoto, Kyoto, 615-0035

  • Novartis Investigative Site

    Mito, Ibaraki, 311-4153

  • Novartis Investigative Site

    Nerima-ku, Tokyo, 177-0041

  • Novartis Investigative Site

    Nerima-ku, Tokyo, 177-0051

  • Novartis Investigative Site

    Osaka, Osaka, 530-0001

  • Novartis Investigative Site

    Osaka, Osaka, 534-0021

  • Novartis Investigative Site

    Ōta-ku, Tokyo, 144-0051

  • Novartis Investigative Site

    Saitama, Saitama, 336-0963

  • Novartis Investigative Site

    Sayama, Saitama, 350-1305

  • Novartis Investigative Site

    Sendai, Miyagi, 980-0021

  • Novartis Investigative Site

    Suginami-ku, Tokyo, 166-0004

  • Novartis Investigative Site

    Takatsuki, Osaka, 569-1096

  • Novartis Investigative Site

    Tokorozawa, Saitama, 359-1161

  • Novartis Investigative Site

    Yatsushiro, Kumamoto, 866-8533

  • Novartis Investigative Site

    Yokohama, Kanagawa, 221-0802

Other trials in Japan

About this study

Official title: A 12-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Equa (Vildagliptin) 50 mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid add-on therapy to improve overall glycemic control in patients with T2DM inadequately controlled by insulin, with or without concomitant metformin treatment. It was agreed with PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.

Being tested
Vildagliptin (LAF237), Placebo, Insulin, Metformin
Keywords
Diabetes Mellitus (DM) ,, diabetes,, noninsulin-dependent diabetes mellitus (NIDDM),, adult-onset diabetes,, high blood sugar,, T2DM
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vildagliptin (LAF237)Drug

    Also called Vildagliptin

    Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily

  • PlaceboDrug

    Matching placebo of vildagliptin 50 mg twice daily

  • InsulinDrug

    Patients continued their prescribed insulin dose. The dose of insulin remained within a 10% increase of the baseline dose throughout the trial (with no change in frequency or insulin type) unless dose adjustments were required for safety reasons.

    The insulin dose was allowed to be decreased for safety reasons at anytime without specific dose limits at the Investigator's discretion.

  • MetforminDrug

    Patients continued their prescribed metformin dose, if applicable.

Study groups in NCT02002221
Study groupRoleWhat they receive
Vildagliptin (LAF237)ExperimentalPatients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
Receives: Drug: Vildagliptin (LAF237); Drug: Insulin; Drug: Metformin
PlaceboPlacebo comparatorIn this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
Receives: Drug: Placebo; Drug: Insulin; Drug: Metformin

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 12 Weeks Between Treatment Groups

    HbA1c was performed on a blood sample obtained and measured by high performance liquid chromatography performed at a central laboratory.

    Measured: Baseline, week 12

Secondary outcomes (4)

  1. Percentage of Patients Meeting Responder Rates in HbA1c

    Responder rate was analyzed in categories: Criterion 1- Endpoint HbA1c ≤ 6.5%, Criterion 2- Endpoint HbA1c < 7% , Criterion 3- Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8%, Criterion 4- HbA1c reduction from baseline at endpoint ≥ 1%, Criterion 5- HbA1c reduction from baseline at endpoint ≥ 0.5%. The number of patients analyzed for Criterion 1 and 2 include only patients with baseline HbA1c ≥ 7% (> 6.5%) and endpoint HbA1c measurement. The number of patients analyzed for Criterion 3 includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c measurement. The number of patients analyzed for Criterion 4 and 5 include patients with both baseline and endpoint HbA1c measurements.

    Measured: Baseline, week 12

  2. Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks

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

    Measured: Baseline, week 12

  3. Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia

    Hypoglycemic events are defined as a) symptoms suggestive of hypoglycemia, where the patient is able to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 1), b) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 2), c) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and no plasma glucose measurement is available (suspected grade 2)

    Measured: 12 weeks

  4. Number of Participants With Adverse Events, Serious Adverse Events and Death

    The occurrence of adverse events was sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, vital sign, 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: 12 weeks

Timeline

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

  1. First posted5 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02002221
Sponsor's protocol ID
CLAF237A1405
Status last verified
Jan 2016
First submitted
29 Nov 2013
Last updated
1 Mar 2016

Publications

  • Hirose T, Suzuki M, Tsumiyama I. Efficacy and Safety of Vildagliptin as an Add-on to Insulin with or without Metformin in Japanese Patients with Type 2 Diabetes Mellitus: A 12-week, Double-Blind, Randomized Study. Diabetes Ther. 2015 Dec;6(4):559-571. doi: 10.1007/s13300-015-0147-6. Epub 2015 Nov 30.

    PubMed 26620049

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vildagliptin (LAF237), Insulin and Metformin in people with Type 2 Diabetes Mellitus (T2DM), run by Novartis Pharmaceuticals at 31 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 4 inclusion and 5 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 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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 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 1 Mar 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 Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups (time frame: Baseline, week 12). 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 NCT02002221, 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 1 Mar 2016.

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