Trial Outcomes & Findings for Monotherapy Study of MP-513 in Patients With Type 2 Diabetes (NCT NCT00998881)
NCT ID: NCT00998881
Last Updated: 2026-01-02
Results Overview
The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.
COMPLETED
PHASE3
203 participants
12 weeks
2026-01-02
Participant Flow
Participant milestones
| Measure |
Placebo
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 20 mg
Teneligliptin 20 mg, orally, once daily
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
99
|
|
Overall Study
COMPLETED
|
96
|
97
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 20 mg
Teneligliptin 20 mg, orally, once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Personal matter
|
1
|
0
|
Baseline Characteristics
Monotherapy Study of MP-513 in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=104 Participants
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 20 mg
n=99 Participants
Teneligliptin 20 mg, orally, once daily
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 10.1 • n=228 Participants
|
58.5 years
STANDARD_DEVIATION 10.0 • n=115 Participants
|
58.9 years
STANDARD_DEVIATION 10.0 • n=343 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=228 Participants
|
31 Participants
n=115 Participants
|
65 Participants
n=343 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=228 Participants
|
68 Participants
n=115 Participants
|
138 Participants
n=343 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.
The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.
Outcome measures
| Measure |
Placebo
n=104 Participants
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 20 mg
n=99 Participants
Teneligliptin 20 mg, orally, once daily
|
|---|---|---|
|
Change From Baseline in HbA1c at Week 12
|
0.17 Percent
Standard Error 0.05
|
-0.62 Percent
Standard Error 0.05
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.
The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.
Outcome measures
| Measure |
Placebo
n=104 Participants
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 20 mg
n=99 Participants
Teneligliptin 20 mg, orally, once daily
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 12
|
-0.2 mg / dL
Standard Error 1.8
|
-19.2 mg / dL
Standard Error 1.8
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.
The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.
Outcome measures
| Measure |
Placebo
n=96 Participants
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 20 mg
n=97 Participants
Teneligliptin 20 mg, orally, once daily
|
|---|---|---|
|
Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12
|
0.224 mg*h / dL
Standard Error 4.849
|
-73.124 mg*h / dL
Standard Error 4.824
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.
The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.
Outcome measures
| Measure |
Placebo
n=96 Participants
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 20 mg
n=97 Participants
Teneligliptin 20 mg, orally, once daily
|
|---|---|---|
|
Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12
|
-3.2 mg / dL
Standard Error 3.6
|
-47.9 mg / dL
Standard Error 3.5
|
Adverse Events
Placebo
Teneligliptin 20 mg
Serious adverse events
| Measure |
Placebo
n=104 participants at risk
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 20 mg
n=99 participants at risk
Teneligliptin 20 mg, orally, once daily
|
|---|---|---|
|
Infections and infestations
Vestibular neuronitis
|
0.96%
1/104
|
0.00%
0/99
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.96%
1/104
|
0.00%
0/99
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.96%
1/104
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Contusion
|
0.96%
1/104
|
0.00%
0/99
|
Other adverse events
| Measure |
Placebo
n=104 participants at risk
Teneligliptin placebo-matching tablets, orally, once daily
|
Teneligliptin 20 mg
n=99 participants at risk
Teneligliptin 20 mg, orally, once daily
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.9%
2/104
|
1.0%
1/99
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/104
|
1.0%
1/99
|
|
Gastrointestinal disorders
Diarrhoea
|
0.96%
1/104
|
0.00%
0/99
|
|
Gastrointestinal disorders
Duodenitis
|
0.96%
1/104
|
0.00%
0/99
|
|
Gastrointestinal disorders
Dyspepsia
|
0.96%
1/104
|
1.0%
1/99
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/104
|
1.0%
1/99
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/104
|
2.0%
2/99
|
|
Gastrointestinal disorders
Periodontitis
|
3.8%
4/104
|
1.0%
1/99
|
|
Gastrointestinal disorders
Stomatitis
|
0.96%
1/104
|
0.00%
0/99
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/104
|
2.0%
2/99
|
|
Gastrointestinal disorders
Gastric xanthoma
|
0.00%
0/104
|
1.0%
1/99
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/104
|
1.0%
1/99
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.96%
1/104
|
0.00%
0/99
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/104
|
1.0%
1/99
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.96%
1/104
|
1.0%
1/99
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/104
|
2.0%
2/99
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/104
|
1.0%
1/99
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.96%
1/104
|
0.00%
0/99
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/104
|
2.0%
2/99
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
4/104
|
0.00%
0/99
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/104
|
1.0%
1/99
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.96%
1/104
|
0.00%
0/99
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/104
|
1.0%
1/99
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.96%
1/104
|
0.00%
0/99
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/104
|
1.0%
1/99
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.96%
1/104
|
0.00%
0/99
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.96%
1/104
|
1.0%
1/99
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.96%
1/104
|
1.0%
1/99
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/104
|
1.0%
1/99
|
|
Renal and urinary disorders
Micturition disorder
|
0.96%
1/104
|
0.00%
0/99
|
|
General disorders
Chest pain
|
0.96%
1/104
|
0.00%
0/99
|
|
General disorders
Feeling abnormal
|
0.96%
1/104
|
0.00%
0/99
|
|
General disorders
Malaise
|
0.96%
1/104
|
1.0%
1/99
|
|
General disorders
Vessel puncture site haematoma
|
0.96%
1/104
|
0.00%
0/99
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
4/104
|
1.0%
1/99
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
3/104
|
0.00%
0/99
|
|
Investigations
Blood creatine phosphokinase increased
|
3.8%
4/104
|
2.0%
2/99
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.96%
1/104
|
0.00%
0/99
|
|
Investigations
Blood triglycerides increased
|
3.8%
4/104
|
0.00%
0/99
|
|
Investigations
Blood urea increased
|
0.00%
0/104
|
1.0%
1/99
|
|
Investigations
Blood uric acid increased
|
0.96%
1/104
|
2.0%
2/99
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.96%
1/104
|
0.00%
0/99
|
|
Investigations
Glucose urine present
|
6.7%
7/104
|
4.0%
4/99
|
|
Investigations
Blood urine present
|
2.9%
3/104
|
2.0%
2/99
|
|
Investigations
White blood cell count increased
|
0.00%
0/104
|
2.0%
2/99
|
|
Investigations
Protein urine present
|
2.9%
3/104
|
2.0%
2/99
|
|
Investigations
Urine ketone body present
|
1.9%
2/104
|
1.0%
1/99
|
|
Investigations
Blood alkaline phosphatase increased
|
1.9%
2/104
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.96%
1/104
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.96%
1/104
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/104
|
2.0%
2/99
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/104
|
1.0%
1/99
|
|
Infections and infestations
Cystitis
|
0.96%
1/104
|
1.0%
1/99
|
|
Infections and infestations
Gastroenteritis
|
2.9%
3/104
|
2.0%
2/99
|
|
Infections and infestations
Hordeolum
|
0.96%
1/104
|
0.00%
0/99
|
|
Infections and infestations
Influenza
|
0.96%
1/104
|
1.0%
1/99
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
7/104
|
12.1%
12/99
|
|
Infections and infestations
Pharyngitis
|
0.96%
1/104
|
1.0%
1/99
|
|
Infections and infestations
Tinea pedis
|
2.9%
3/104
|
0.00%
0/99
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/104
|
1.0%
1/99
|
|
Infections and infestations
Alveolar osteitis
|
0.96%
1/104
|
0.00%
0/99
|
|
Infections and infestations
Oral herpes
|
0.96%
1/104
|
1.0%
1/99
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/104
|
1.0%
1/99
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/104
|
1.0%
1/99
|
|
Metabolism and nutrition disorders
Gout
|
0.96%
1/104
|
0.00%
0/99
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.96%
1/104
|
0.00%
0/99
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.96%
1/104
|
1.0%
1/99
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.96%
1/104
|
0.00%
0/99
|
|
Psychiatric disorders
Insomnia
|
1.9%
2/104
|
2.0%
2/99
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/104
|
1.0%
1/99
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/104
|
1.0%
1/99
|
|
Nervous system disorders
Dizziness
|
0.00%
0/104
|
1.0%
1/99
|
|
Nervous system disorders
Headache
|
0.96%
1/104
|
0.00%
0/99
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/104
|
1.0%
1/99
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/104
|
1.0%
1/99
|
|
Eye disorders
Blepharospasm
|
0.96%
1/104
|
0.00%
0/99
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/104
|
1.0%
1/99
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/104
|
1.0%
1/99
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.96%
1/104
|
0.00%
0/99
|
|
Cardiac disorders
Palpitations
|
0.00%
0/104
|
1.0%
1/99
|
|
Vascular disorders
Hypertension
|
1.9%
2/104
|
1.0%
1/99
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/104
|
1.0%
1/99
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/104
|
1.0%
1/99
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
3.8%
4/104
|
4.0%
4/99
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
0.00%
0/104
|
1.0%
1/99
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
2/104
|
0.00%
0/99
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.96%
1/104
|
0.00%
0/99
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/104
|
1.0%
1/99
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.96%
1/104
|
1.0%
1/99
|
|
Gastrointestinal disorders
Colonic polyp
|
1.9%
2/104
|
3.0%
3/99
|
|
Infections and infestations
Acute sinusitis
|
0.96%
1/104
|
0.00%
0/99
|
|
Infections and infestations
Bronchitis
|
3.8%
4/104
|
3.0%
3/99
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER