A Phase 3 interventional study of Teneligliptin 20mg and Placebo in Type 2 Diabetes Mellitus, sponsored by Tanabe Pharma Corporation. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Tanabe Pharma Corporation · Phase 3, Interventional, and Treatment
This study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with metformin.
9,362 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,317 are open to participants now.
This study's enrollment of 247 is above the median of 80 across 7,528 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →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.
Exclusion Criteria:
Teneligliptin (20mg once daily) for 24 weeks in combination with metformin
Drug: Teneligliptin 20mg · Drug: Metformin ≥ 1000 mg
Placebo for 24 weeks in combination with metformin
Drug: Placebo · Drug: Metformin ≥ 1000 mg
The Changes in HbA1c at Week 24
The change in HbA1c from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.
Time frame: at Day 1(baseline) and Week 24
The Changes in Fasting Plasma Glucose (FPG) at Week 24
The change in FPG from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.
Time frame: at Day 1(baseline) and Week 24
| Milestone | Teneligliptin 20mg + Metformin | Placebo + Metformin |
|---|---|---|
| Started | 123 | 124 |
| Fas | 122 | 124 |
| Completed | 99 | 81 |
| Not completed | 24 | 43 |
| Withdrew: Adverse event | 2 | 2 |
| Withdrew: Lost to follow-up | 0 | 2 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Protocol violation | 1 | 3 |
| Withdrew: Withdrawal by subject | 4 | 5 |
| Withdrew: Other | 17 | 29 |
The change in HbA1c from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.
| percentage of HbA1c | Teneligliptin 20mg + Metformin | Placebo + Metformin |
|---|---|---|
| The Changes in HbA1c at Week 24 | -0.72 ± 0.07 | -0.01 ± 0.07 |
The change in FPG from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.
| mg/dL | Teneligliptin 20mg + Metformin | Placebo + Metformin |
|---|---|---|
| The Changes in Fasting Plasma Glucose (FPG) at Week 24 | -13.5 ± 3.3 | 3.0 ± 3.3 |
Collected over 24 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Teneligliptin 20mg + Metformin | 0/124 (0%) | 4/124 (3.2%) | 35/124 (28.2%) |
| Placebo + Metformin | 0/123 (0%) | 6/123 (4.9%) | 43/123 (35%) |
| Event | Teneligliptin 20mg + Metformin | Placebo + Metformin |
|---|---|---|
| Cerebral infarctionNervous system disorders | 2/124 | 1/123 |
| ArrhythmiaCardiac disorders | 0/124 | 1/123 |
| Sinus node dysfunctionCardiac disorders | 0/124 | 1/123 |
| CataractEye disorders | 0/124 | 1/123 |
| Gastric polypsGastrointestinal disorders | 0/124 | 1/123 |
| Ligament sprainInjury, poisoning and procedural complications | 0/124 | 1/123 |
| HypertensionVascular disorders | 0/124 | 1/123 |
| Subarachnoid haemorrhageInjury, poisoning and procedural complications | 1/124 | 0/123 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 1/124 | 0/123 |
| OsteoarthropathyMusculoskeletal and connective tissue disorders | 1/124 | 0/123 |
| Event | Teneligliptin 20mg + Metformin | Placebo + Metformin |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 14/124 | 22/123 |
| HyperuricaemiaMetabolism and nutrition disorders | 11/124 | 13/123 |
| HyperlipidaemiaMetabolism and nutrition disorders | 8/124 | 7/123 |
| HypertensionVascular disorders | 3/124 | 7/123 |
| ProteinuriaRenal and urinary disorders | 7/124 | 5/123 |
FAS: All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period and have at least one post-baseline efficacy observation. Subjects who were not diagnosed with type 2 diabetes mellitus were excluded.
| Age, Continuous(years) | Teneligliptin 20mg + Metformin | Placebo + Metformin | Total |
|---|---|---|---|
| Mean | 56.0 ± 9.8 | 54.7 ± 10.1 | 55.3 ± 10.0 |
| Sex: Female, Male(Participants) | Teneligliptin 20mg + Metformin | Placebo + Metformin | Total |
|---|---|---|---|
| Female | 41 | 57 | 98 |
| Male | 81 | 67 | 148 |
| Race (NIH/OMB)(Participants) | Teneligliptin 20mg + Metformin | Placebo + Metformin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 122 | 124 | 246 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Tanabe Pharma Corporation