Trial Outcomes & Findings for Efficacy and Safety of Teneligliptin in Combination With Metformin in Chinese Patients With Type 2 Diabetes Mellitus (NCT NCT02924064)
NCT ID: NCT02924064
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
247 participants
Primary outcome timeframe
at Day 1(baseline) and Week 24
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
Teneligliptin 20mg + Metformin
Teneligliptin (20 mg once daily) for 24 weeks in combination with metformin.
|
Placebo + Metformin
Placebo for 24 weeks in combination with metformin.
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
124
|
|
Overall Study
FAS
|
122
|
124
|
|
Overall Study
COMPLETED
|
99
|
81
|
|
Overall Study
NOT COMPLETED
|
24
|
43
|
Reasons for withdrawal
| Measure |
Teneligliptin 20mg + Metformin
Teneligliptin (20 mg once daily) for 24 weeks in combination with metformin.
|
Placebo + Metformin
Placebo for 24 weeks in combination with metformin.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Other
|
17
|
29
|
Baseline Characteristics
Efficacy and Safety of Teneligliptin in Combination With Metformin in Chinese Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Teneligliptin 20mg + Metformin
n=122 Participants
Teneligliptin (20 mg once daily) for 24 weeks in combination with metformin.
|
Placebo + Metformin
n=124 Participants
Placebo for 24 weeks in combination with metformin.
|
Total
n=246 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 9.8 • n=37 Participants
|
54.7 years
STANDARD_DEVIATION 10.1 • n=56 Participants
|
55.3 years
STANDARD_DEVIATION 10.0 • n=82 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=37 Participants
|
57 Participants
n=56 Participants
|
98 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=37 Participants
|
67 Participants
n=56 Participants
|
148 Participants
n=82 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Asian
|
122 Participants
n=37 Participants
|
124 Participants
n=56 Participants
|
246 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 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 + Metformin
n=122 Participants
Teneligliptin (20 mg once daily) for 24 weeks in combination with metformin.
|
Placebo + Metformin
n=124 Participants
Placebo for 24 weeks in combination with metformin.
|
|---|---|---|
|
The Changes in HbA1c at Week 24
|
-0.72 percentage of HbA1c
Standard Error 0.07
|
-0.01 percentage of HbA1c
Standard Error 0.07
|
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 + Metformin
n=122 Participants
Teneligliptin (20 mg once daily) for 24 weeks in combination with metformin.
|
Placebo + Metformin
n=124 Participants
Placebo for 24 weeks in combination with metformin.
|
|---|---|---|
|
The Changes in Fasting Plasma Glucose (FPG) at Week 24
|
-13.5 mg/dL
Standard Error 3.3
|
3.0 mg/dL
Standard Error 3.3
|
Adverse Events
Teneligliptin 20mg + Metformin
Serious events: 4 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo + Metformin
Serious events: 6 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teneligliptin 20mg + Metformin
n=124 participants at risk
Teneligliptin (20 mg once daily) for 24 weeks in combination with metformin.
|
Placebo + Metformin
n=123 participants at risk
Placebo for 24 weeks in combination with metformin.
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/124 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
0.81%
1/123 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/124 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
0.81%
1/123 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
|
Eye disorders
Cataract
|
0.00%
0/124 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
0.81%
1/123 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/124 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
0.81%
1/123 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/124 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
0.81%
1/123 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.81%
1/124 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
0.00%
0/123 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.81%
1/124 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
0.00%
0/123 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthropathy
|
0.81%
1/124 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
0.00%
0/123 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
|
Nervous system disorders
Cerebral infarction
|
1.6%
2/124 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
0.81%
1/123 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
|
Vascular disorders
Hypertension
|
0.00%
0/124 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
0.81%
1/123 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
Other adverse events
| Measure |
Teneligliptin 20mg + Metformin
n=124 participants at risk
Teneligliptin (20 mg once daily) for 24 weeks in combination with metformin.
|
Placebo + Metformin
n=123 participants at risk
Placebo for 24 weeks in combination with metformin.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
11.3%
14/124 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
17.9%
22/123 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
6.5%
8/124 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
5.7%
7/123 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
8.9%
11/124 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
10.6%
13/123 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
|
Renal and urinary disorders
Proteinuria
|
5.6%
7/124 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
4.1%
5/123 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
|
Vascular disorders
Hypertension
|
2.4%
3/124 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
5.7%
7/123 • 24 weeks
All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period. One subject who had been randomized in placebo group was handled as Teneligliptin group, because the subject had been administered Teneligliptin mistakenly.
|
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