Trial Outcomes & Findings for Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus (NCT NCT02916706)
NCT ID: NCT02916706
Last Updated: 2026-01-06
Results Overview
The change in HbA1c from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
254 participants
Primary outcome timeframe
at Day 1(baseline) and Week 24
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
Teneligliptin 20mg
Teneligliptin (20mg once daily) for 24 weeks
|
Placebo
Placebo for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
127
|
|
Overall Study
FAS
|
125
|
126
|
|
Overall Study
COMPLETED
|
112
|
96
|
|
Overall Study
NOT COMPLETED
|
15
|
31
|
Reasons for withdrawal
| Measure |
Teneligliptin 20mg
Teneligliptin (20mg once daily) for 24 weeks
|
Placebo
Placebo for 24 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
9
|
|
Overall Study
Other
|
5
|
19
|
Baseline Characteristics
Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Teneligliptin 20mg
n=125 Participants
Teneligliptin (20mg once daily) for 24 weeks
|
Placebo
n=126 Participants
Placebo for 24 weeks
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 10.2 • n=9 Participants
|
56.0 years
STANDARD_DEVIATION 10.2 • n=6 Participants
|
54.0 years
STANDARD_DEVIATION 10.3 • n=9 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=9 Participants
|
47 Participants
n=6 Participants
|
87 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=9 Participants
|
79 Participants
n=6 Participants
|
164 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
125 Participants
n=9 Participants
|
126 Participants
n=6 Participants
|
251 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: at Day 1(baseline) and Week 24Population: 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.
The change in HbA1c from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.
Outcome measures
| Measure |
Teneligliptin 20mg
n=125 Participants
Teneligliptin (20mg once daily) for 24 weeks
|
Placebo
n=126 Participants
Placebo for 24 weeks
|
|---|---|---|
|
Change in HbA1c From Baseline to Week 24
|
-0.95 percentage of HbA1c
Standard Error 0.06
|
-0.14 percentage of HbA1c
Standard Error 0.06
|
SECONDARY outcome
Timeframe: at Day 1(baseline) and Week 24Population: 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.
The change in FPG from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.
Outcome measures
| Measure |
Teneligliptin 20mg
n=125 Participants
Teneligliptin (20mg once daily) for 24 weeks
|
Placebo
n=126 Participants
Placebo for 24 weeks
|
|---|---|---|
|
The Changes in Fasting Plasma Glucose (FPG) at Week 24
|
-21.9 mg/dL
Standard Error 2.5
|
-1.4 mg/dL
Standard Error 2.5
|
Adverse Events
Teneligliptin 20mg
Serious events: 6 serious events
Other events: 69 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teneligliptin 20mg
n=127 participants at risk
Teneligliptin (20mg once daily) for 24 weeks
|
Placebo
n=127 participants at risk
Placebo for 24 weeks
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/127 • 24 weeks
|
0.79%
1/127 • 24 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.79%
1/127 • 24 weeks
|
0.00%
0/127 • 24 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.79%
1/127 • 24 weeks
|
0.00%
0/127 • 24 weeks
|
|
Infections and infestations
Appendicitis
|
0.79%
1/127 • 24 weeks
|
0.00%
0/127 • 24 weeks
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.79%
1/127 • 24 weeks
|
0.00%
0/127 • 24 weeks
|
|
Investigations
Blood glucose increased
|
0.00%
0/127 • 24 weeks
|
0.79%
1/127 • 24 weeks
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.79%
1/127 • 24 weeks
|
0.00%
0/127 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/127 • 24 weeks
|
0.79%
1/127 • 24 weeks
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/127 • 24 weeks
|
0.79%
1/127 • 24 weeks
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/127 • 24 weeks
|
0.79%
1/127 • 24 weeks
|
|
Vascular disorders
Hypertension
|
0.79%
1/127 • 24 weeks
|
0.00%
0/127 • 24 weeks
|
Other adverse events
| Measure |
Teneligliptin 20mg
n=127 participants at risk
Teneligliptin (20mg once daily) for 24 weeks
|
Placebo
n=127 participants at risk
Placebo for 24 weeks
|
|---|---|---|
|
Hepatobiliary disorders
Hepatic function abnormal
|
5.5%
7/127 • 24 weeks
|
1.6%
2/127 • 24 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
23.6%
30/127 • 24 weeks
|
15.7%
20/127 • 24 weeks
|
|
Investigations
Protein urine present
|
5.5%
7/127 • 24 weeks
|
3.9%
5/127 • 24 weeks
|
|
Investigations
Urine ketone body present
|
7.1%
9/127 • 24 weeks
|
0.79%
1/127 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.9%
5/127 • 24 weeks
|
7.1%
9/127 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
8.7%
11/127 • 24 weeks
|
4.7%
6/127 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.3%
8/127 • 24 weeks
|
5.5%
7/127 • 24 weeks
|
|
Renal and urinary disorders
Proteinuria
|
7.1%
9/127 • 24 weeks
|
3.9%
5/127 • 24 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.3%
8/127 • 24 weeks
|
3.1%
4/127 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
7/127 • 24 weeks
|
4.7%
6/127 • 24 weeks
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma Corporation
Phone: Please e-mail
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER