CClinicalTrials.gg
Sign In
CompletedNCT00971243Updated Jan 7, 2026Results posted

Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes

A Phase 2 interventional study of MP-513 Lowest Dose and Metformin and MP-513 Low Dose and Metformin in Type 2 Diabetes Mellitus, sponsored by Tanabe Pharma Corporation. Completed at 44 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Tanabe Pharma Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
448
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Insulin resistance
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 448 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Tanabe Pharma Corporation is the lead sponsor of 91 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who are aged ≧ 18 years old.
  • Patients whose HbA1c is ≧ 7.0 % and \< 10.0%.
  • Patients whose BMI is ≧ 20.0 and ≦40.0 ㎏/㎡.
  • Patients who took metformin monotherapy for at least 56 consecutive days at the screening visit.

Exclusion criteria

Exclusion Criteria:

  • Patients with type 1 diabetes or secondary form of diabetes.
  • Patients with heart failure symptoms.
  • Patients with serious diabetic complications.
  • Patients with severe hepatic disorder or severe renal disorder.
  • Patients who are the excessive alcohol addicts.
  • Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
448 participants (actual)

Study arms

  • Experimental
    MP-513 Lowest Dose and Metformin

    Drug: MP-513 Lowest Dose and Metformin

  • Experimental
    MP-513 Low Dose and Metformin

    Drug: MP-513 Low Dose and Metformin

  • Experimental
    MP-513 Medium Dose and Metformin

    Drug: MP-513 Medium Dose and Metformin

  • Experimental
    MP-513 High Dose and Metformin

    Drug: MP-513 High Dose and Metformin

  • Placebo comparator
    Placebo and Metformin

    Drug: Placebo and Metformin

Interventions

  • DrugMP-513 Lowest Dose and Metformin

    MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

  • DrugMP-513 Low Dose and Metformin

    MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

  • DrugMP-513 Medium Dose and Metformin

    MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

  • DrugMP-513 High Dose and Metformin

    MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

  • DrugPlacebo and Metformin

    Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

06

What researchers measure

Primary outcomes

  1. Change in HbA1c From Baseline to Week 24

    The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.

    Time frame: Baseline and Week 24

Secondary outcomes

  1. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24

    Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.

    Time frame: Baseline and Week 24

  2. Adverse Events, Laboratory Tests, Vital Signs, Etc.

    Time frame: Weeks 24, 52

07

Results

Posted Sep 1, 2014

Participant flow

Double Blind Period
Participant flow — Double Blind Period
MilestoneTeneli 5mg+MetTeneli 10mg+MetTeneli 20mg+MetTeneli 40mg+MetPlacebo+Met
Started8793918888
Completed6882727470
Not completed1911191418
Withdrew: Adverse event23223
Withdrew: Lost to follow-up01101
Withdrew: Physician decision106767
Withdrew: Protocol violation20322
Withdrew: Withdrawal by subject41444
Withdrew: Other reasons10201
Open-label Period
Participant flow — Open-label Period
MilestoneTeneli 5mg+MetTeneli 10mg+MetTeneli 20mg+MetTeneli 40mg+MetPlacebo+Met
Started6881717470
Completed6071666464
Not completed8105106
Withdrew: Adverse event10110
Withdrew: Physician decision59372
Withdrew: Protocol violation11101
Withdrew: Withdrawal by subject10021
Withdrew: Other reason00002

Outcome measures

PrimaryChange in HbA1c From Baseline to Week 24

The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.

Time frame:
Baseline and Week 24
Reported as:
Least squares mean · percentage of HbA1c
Change in HbA1c From Baseline to Week 24
percentage of HbA1cTeneli 5mg+MetTeneli 10mg+MetTeneli 20mg+MetTeneli 40mg+MetPlacebo+Met
Change in HbA1c From Baseline to Week 24-0.58 ± 0.07-0.68 ± 0.07-0.76 ± 0.07-0.91 ± 0.07-0.28 ± 0.07
SecondaryChange in Fasting Plasma Glucose (FPG) From Baseline to Week 24

Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.

Time frame:
Baseline and Week 24
Reported as:
Least squares mean · mg/dL
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
mg/dLTeneli 5mg+MetTeneli 10mg+MetTeneli 20mg+MetTeneli 40mg+MetPlacebo+Met
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24-15.54 ± 2.94-13.65 ± 2.83-17.84 ± 2.86-21.85 ± 2.91-3.51 ± 2.95
SecondaryAdverse Events, Laboratory Tests, Vital Signs, Etc.
Time frame:
Weeks 24, 52

Results for this outcome have not been posted.

Adverse events

Collected over 24 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Teneli 5mg+Met—4/87 (4.6%)43/87 (49.4%)
Teneli 10 mg+Met—4/93 (4.3%)43/93 (46.2%)
Teneli 20 mg+Met—3/91 (3.3%)41/91 (45.1%)
Teneli 40 mg+Met—5/88 (5.7%)36/88 (40.9%)
Placebo+Met—6/88 (6.8%)48/88 (54.5%)
Most frequent serious events
Showing 10 of 23
Most frequent serious events
EventTeneli 5mg+MetTeneli 10 mg+MetTeneli 20 mg+MetTeneli 40 mg+MetPlacebo+Met
PNEUMONIAInfections and infestations1/870/930/910/880/88
TRANSIENT ISCHAEMIC ATTACKNervous system disorders1/870/930/910/880/88
ISCHAEMIC STROKENervous system disorders1/870/930/910/880/88
HEPATIC STEATOSISHepatobiliary disorders1/870/930/910/880/88
BRONCHITISInfections and infestations0/870/930/910/881/88
MALIGNANT MELANOMANeoplasms benign, malignant and unspecified (incl cysts and polyps)0/870/930/911/881/88
METASTASES TO LIVERNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/870/930/910/881/88
PROSTATE CANCERNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/870/930/910/881/88
LUNG NEOPLASMNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/870/930/910/881/88
IIIRD NERVE PARALYSISNervous system disorders0/870/930/910/881/88
Most frequent other events
Showing 10 of 196
Most frequent other events
EventTeneli 5mg+MetTeneli 10 mg+MetTeneli 20 mg+MetTeneli 40 mg+MetPlacebo+Met
NASOPHARYNGITISInfections and infestations6/874/932/917/886/88
HYPERTENSIONVascular disorders5/872/933/912/882/88
CYSTITISInfections and infestations2/874/931/915/881/88
HEADACHENervous system disorders1/872/935/911/881/88
DIARRHOEAGastrointestinal disorders1/872/935/911/883/88
BRONCHITISInfections and infestations3/873/930/910/881/88
GASTROENTERITISInfections and infestations1/870/931/913/882/88
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations2/871/933/910/882/88
HYPERTRIGLYCERIDAEMIAMetabolism and nutrition disorders0/871/933/911/881/88
URINARY TRACT INFECTIONInfections and infestations2/873/932/910/882/88

Baseline characteristics

Age, Continuous
Age, Continuous(years)Teneli 5mg+MetTeneli 10mg+MetTeneli 20mg+MetTeneli 40mg+MetPlacebo+MetTotal
Mean58.8 ± 7.758.5 ± 8.458.3 ± 9.558.2 ± 8.658.9 ± 8.258.5 ± 8.5
Sex: Female, Male
Sex: Female, Male(Participants)Teneli 5mg+MetTeneli 10mg+MetTeneli 20mg+MetTeneli 40mg+MetPlacebo+MetTotal
Female4142353641195
Male4651565247252
08

Study locations

44 sites
  • Aalborg, Denmark
  • Ballerup Municipality, Denmark
  • Vejle, Denmark
  • Falkensee, Germany
  • Hamburg, Germany
  • Karlsruhe, Germany
  • Kiel, Germany
  • Ludwigshafen, Germany
  • Lübeck, Germany
  • Mainz, Germany
  • Ádám, Hungary
  • Békéscsaba, Hungary
  • Budapest, Hungary
  • Gyöngyös, Hungary
  • Kaposvár, Hungary
  • Miskolc, Hungary
  • Nyíregyháza, Hungary
  • Semmelweis, Hungary
  • Szentes, Hungary
  • Szigetvár, Hungary
  • Kaunas, Lithuania
  • Klaipėda, Lithuania
  • Vilnius, Lithuania
  • Gdansk, Poland
  • Krakow, Poland
  • Leszno, Poland
  • Lodz, Poland
  • Niemodlin, Poland
  • Płock, Poland
  • Warsaw, Poland
  • Wroclaw, Poland
  • Brasov, Romania
  • Bucharest, Romania
  • Galati, Romania
  • Ploieşti, Romania
  • Timișoara, Romania
  • Timuș, Romania
  • Addlestone, United Kingdom
  • Ayr, United Kingdom
  • Bournemouth, United Kingdom
  • East Sussex, United Kingdom
  • Edinburgh, United Kingdom
  • Oldham, United Kingdom
  • York, United Kingdom
09

References and documents

Publications

  • Kadowaki T, Kondo K. Efficacy and safety of teneligliptin added to glimepiride in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study with an open-label, long-term extension. Diabetes Obes Metab. 2014 May;16(5):418-25. doi: 10.1111/dom.12235. Epub 2013 Dec 10. PubMed 24205974 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00971243
Lead sponsor
Tanabe Pharma Corporation
Responsible party
Sponsor
First posted
Sep 3, 2009
Start date
Aug 2009
Primary completion
Apr 2011
Completion
Apr 2011
Results posted
Sep 1, 2014
Last update
Jan 7, 2026

Study contacts

David Kerr, Dr
principal investigator · Royal Bournemouth Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus, Type 2→

Other studies from this sponsor

Tanabe Pharma Corporation

Start the discussion