Trial Outcomes & Findings for Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes (NCT NCT02081599)
NCT ID: NCT02081599
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 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
148 participants
Primary outcome timeframe
at Week 0 and Week 16
Results posted on
2026-01-02
Participant Flow
Participant milestones
| Measure |
Placebo/Teneli (Teneligliptin) + Insulin
Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
|
Teneli (Teneligliptin) /Teneli + Insulin
Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
|
|---|---|---|
|
Period 1：Double-blind Period
STARTED
|
71
|
77
|
|
Period 1：Double-blind Period
COMPLETED
|
63
|
75
|
|
Period 1：Double-blind Period
NOT COMPLETED
|
8
|
2
|
|
Period 2：Open-label Period
STARTED
|
63
|
75
|
|
Period 2：Open-label Period
COMPLETED
|
57
|
71
|
|
Period 2：Open-label Period
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Placebo/Teneli (Teneligliptin) + Insulin
Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
|
Teneli (Teneligliptin) /Teneli + Insulin
Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
|
|---|---|---|
|
Period 1：Double-blind Period
Adverse Event
|
3
|
0
|
|
Period 1：Double-blind Period
Lack of Efficacy
|
2
|
1
|
|
Period 1：Double-blind Period
Physician Decision
|
1
|
0
|
|
Period 1：Double-blind Period
Protocol Violation
|
0
|
1
|
|
Period 1：Double-blind Period
Withdrawal by Subject
|
1
|
0
|
|
Period 1：Double-blind Period
stopping criteria
|
1
|
0
|
|
Period 2：Open-label Period
Adverse Event
|
1
|
0
|
|
Period 2：Open-label Period
Lack of Efficacy
|
2
|
4
|
|
Period 2：Open-label Period
Physician Decision
|
1
|
0
|
|
Period 2：Open-label Period
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo/Teneli (Teneligliptin) + Insulin
n=71 Participants
Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
|
Teneli (Teneligliptin) /Teneli + Insulin
n=77 Participants
Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
49 Participants
n=228 Participants
|
46 Participants
n=115 Participants
|
95 Participants
n=343 Participants
|
|
Age, Customized
>=65 years
|
22 Participants
n=228 Participants
|
31 Participants
n=115 Participants
|
53 Participants
n=343 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=228 Participants
|
18 Participants
n=115 Participants
|
36 Participants
n=343 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=228 Participants
|
59 Participants
n=115 Participants
|
112 Participants
n=343 Participants
|
PRIMARY outcome
Timeframe: at Week 0 and Week 16Population: 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 post baseline double-blind observed value was carried forward and used for Week 16 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 16. 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/Teneli (Teneligliptin) + Insulin
n=71 Participants
Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
|
Teneli (Teneligliptin) /Teneli + Insulin
n=77 Participants
Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
|
|---|---|---|
|
Change From Baseline in HbA1c
|
-0.07 percentage of HbA1c
Standard Error 0.08
|
-0.87 percentage of HbA1c
Standard Error 0.08
|
SECONDARY outcome
Timeframe: at Week 0 and Week 16Population: 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 post baseline double-blind observed value was carried forward and used for Week 16 where data was missing.
The change from Baseline in Fasting Plasma Glucose collected at Week 16. 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/Teneli (Teneligliptin) + Insulin
n=70 Participants
Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
|
Teneli (Teneligliptin) /Teneli + Insulin
n=77 Participants
Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose
|
8.0 mg/dL
Standard Error 4.6
|
-5.4 mg/dL
Standard Error 4.4
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 16Population: 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 16. 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/Teneli (Teneligliptin) + Insulin
n=63 Participants
Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
|
Teneli (Teneligliptin) /Teneli + Insulin
n=74 Participants
Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
|
|---|---|---|
|
Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose
|
9.827 mg*hr/dL
Standard Error 11.437
|
-54.035 mg*hr/dL
Standard Error 10.552
|
SECONDARY outcome
Timeframe: at Week 0 and Week 16Population: 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 16. 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/Teneli (Teneligliptin) + Insulin
n=63 Participants
Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
|
Teneli (Teneligliptin) /Teneli + Insulin
n=74 Participants
Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
|
|---|---|---|
|
Change From Baseline in 2-hour Postprandial Plasma Glucose
|
3.0 mg/dL
Standard Error 7.6
|
-42.9 mg/dL
Standard Error 7.0
|
Adverse Events
Placebo/Teneli (Teneligliptin) + Insulin(Data Through Week 16)
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Teneli (Teneligliptin)/Teneli + Insulin(Data Through Week 16)
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo/Teneli(Teneligliptin)+Insulin(Data From Week 16 to 52)
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Teneli (Teneligliptin) /Teneli + Insulin(Data Through Week 52)
Serious events: 5 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Teneli (Teneligliptin) + Insulin(Data Through Week 16)
n=71 participants at risk
Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown.
|
Teneli (Teneligliptin)/Teneli + Insulin(Data Through Week 16)
n=77 participants at risk
Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown.
|
Placebo/Teneli(Teneligliptin)+Insulin(Data From Week 16 to 52)
n=63 participants at risk
Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 16 to Week 52 were shown.
|
Teneli (Teneligliptin) /Teneli + Insulin(Data Through Week 52)
n=77 participants at risk
Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 52 were shown.
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
1.4%
1/71
|
0.00%
0/77
|
0.00%
0/63
|
0.00%
0/77
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage III
|
1.4%
1/71
|
0.00%
0/77
|
0.00%
0/63
|
0.00%
0/77
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/71
|
1.3%
1/77
|
0.00%
0/63
|
1.3%
1/77
|
|
Infections and infestations
Bronchitis
|
0.00%
0/71
|
0.00%
0/77
|
1.6%
1/63
|
0.00%
0/77
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/71
|
0.00%
0/77
|
1.6%
1/63
|
0.00%
0/77
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/71
|
0.00%
0/77
|
1.6%
1/63
|
0.00%
0/77
|
|
Eye disorders
Cataract
|
0.00%
0/71
|
0.00%
0/77
|
0.00%
0/63
|
2.6%
2/77
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/71
|
0.00%
0/77
|
0.00%
0/63
|
1.3%
1/77
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/71
|
0.00%
0/77
|
1.6%
1/63
|
0.00%
0/77
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/71
|
0.00%
0/77
|
1.6%
1/63
|
0.00%
0/77
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/71
|
0.00%
0/77
|
1.6%
1/63
|
0.00%
0/77
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/71
|
0.00%
0/77
|
1.6%
1/63
|
1.3%
1/77
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/71
|
0.00%
0/77
|
0.00%
0/63
|
1.3%
1/77
|
Other adverse events
| Measure |
Placebo/Teneli (Teneligliptin) + Insulin(Data Through Week 16)
n=71 participants at risk
Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown.
|
Teneli (Teneligliptin)/Teneli + Insulin(Data Through Week 16)
n=77 participants at risk
Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown.
|
Placebo/Teneli(Teneligliptin)+Insulin(Data From Week 16 to 52)
n=63 participants at risk
Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 16 to Week 52 were shown.
|
Teneli (Teneligliptin) /Teneli + Insulin(Data Through Week 52)
n=77 participants at risk
Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 52 were shown.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
18.3%
13/71
|
7.8%
6/77
|
20.6%
13/63
|
28.6%
22/77
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.0%
5/71
|
11.7%
9/77
|
11.1%
7/63
|
27.3%
21/77
|
|
Infections and infestations
Bronchitis
|
1.4%
1/71
|
1.3%
1/77
|
4.8%
3/63
|
5.2%
4/77
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/71
|
3.9%
3/77
|
4.8%
3/63
|
5.2%
4/77
|
|
Infections and infestations
Pharyngitis
|
1.4%
1/71
|
1.3%
1/77
|
1.6%
1/63
|
5.2%
4/77
|
|
Gastrointestinal disorders
Constipation
|
2.8%
2/71
|
3.9%
3/77
|
4.8%
3/63
|
10.4%
8/77
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/71
|
0.00%
0/77
|
1.6%
1/63
|
5.2%
4/77
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER