Trial Outcomes & Findings for Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus (NCT NCT02737891)
NCT ID: NCT02737891
Last Updated: 2020-05-14
Results Overview
24-hour heart rate monitoring was based on telemetry measurements at baseline (Day -1 to 1, V2) and at the end of treatment (Day 90 to 91, V10). The heart rate was measured every minute and the mean was recorded for every hour.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline to Day 90
Results posted on
2020-05-14
Participant Flow
Participant milestones
| Measure |
Tesofensine/Metoprolol
Oral tablets Tesofensine/Metoprolol
Tesofensine/Metoprolol: Tesofensine 0.5 mg + Metoprolol 100 mg
|
Placebo
Placebo tablets matching oral Tesofensine/Metoprolol
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Tesofensine/Metoprolol
n=30 Participants
Oral tablets Tesofensine/Metoprolol
Tesofensine/Metoprolol: Tesofensine 0.5 mg + Metoprolol 100 mg
|
Placebo
n=30 Participants
Placebo tablets matching oral Tesofensine/Metoprolol
Placebo
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 7 • n=5 Participants
|
64 years
STANDARD_DEVIATION 5 • n=7 Participants
|
64 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 9024-hour heart rate monitoring was based on telemetry measurements at baseline (Day -1 to 1, V2) and at the end of treatment (Day 90 to 91, V10). The heart rate was measured every minute and the mean was recorded for every hour.
Outcome measures
| Measure |
Tesofensine/Metoprolol
n=30 Participants
Oral tablets Tesofensine/Metoprolol
Tesofensine/Metoprolol: Tesofensine 0.5 mg + Metoprolol 100 mg
|
Placebo
n=30 Participants
Placebo tablets matching oral Tesofensine/Metoprolol
Placebo
|
|---|---|---|
|
Effects of Co-administration of Tesofensine/Metoprolol Treatment vs. Placebo on 24-hour Mean Heart Rate
|
67 beats per minutes (BPM)
Standard Deviation 7
|
70 beats per minutes (BPM)
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Baseline to Day 90HbA1c was measured from blood samples collected at baseline (Day 1, V2) and at the end of treatment (Day 90, V10). Additional HbA1c measurements were done during various visits (V6, V8 and V12).
Outcome measures
| Measure |
Tesofensine/Metoprolol
n=30 Participants
Oral tablets Tesofensine/Metoprolol
Tesofensine/Metoprolol: Tesofensine 0.5 mg + Metoprolol 100 mg
|
Placebo
n=30 Participants
Placebo tablets matching oral Tesofensine/Metoprolol
Placebo
|
|---|---|---|
|
Change From Baseline to End of Treatment in HbA1c
|
7.3 percentage of HbA1c
Standard Deviation 0.6
|
7.4 percentage of HbA1c
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline to Day 90Change in kg body weight measured from baseline to day 90
Outcome measures
| Measure |
Tesofensine/Metoprolol
n=30 Participants
Oral tablets Tesofensine/Metoprolol
Tesofensine/Metoprolol: Tesofensine 0.5 mg + Metoprolol 100 mg
|
Placebo
n=30 Participants
Placebo tablets matching oral Tesofensine/Metoprolol
Placebo
|
|---|---|---|
|
Change From Baseline to End of Treatment in Body Weight
|
-3.5 kg
Standard Deviation 19.9
|
-0.3 kg
Standard Deviation 12.9
|
Adverse Events
Tesofensine/Metoprolol
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tesofensine/Metoprolol
n=30 participants at risk
Oral tablets Tesofensine/Metoprolol
Tesofensine/Metoprolol: Tesofensine 0.5 mg + Metoprolol 100 mg
|
Placebo
n=30 participants at risk
Placebo tablets matching oral Tesofensine/Metoprolol
Placebo
|
|---|---|---|
|
Metabolism and nutrition disorders
cholelithiasis
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
Other adverse events
| Measure |
Tesofensine/Metoprolol
n=30 participants at risk
Oral tablets Tesofensine/Metoprolol
Tesofensine/Metoprolol: Tesofensine 0.5 mg + Metoprolol 100 mg
|
Placebo
n=30 participants at risk
Placebo tablets matching oral Tesofensine/Metoprolol
Placebo
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Cardiac disorders
Tachycardia
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Eye disorders
Visual impairment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Gastrointestinal disorders
Abnormal faeces
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 2 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Gastrointestinal disorders
Dental caries
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
6.7%
2/30 • Number of events 3 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
4/30 • Number of events 4 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Gastrointestinal disorders
Gastric disorder
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
10.0%
3/30 • Number of events 3 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Gastrointestinal disorders
Nausea
|
23.3%
7/30 • Number of events 11 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
6.7%
2/30 • Number of events 2 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Gastrointestinal disorders
Toothache
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30 • Number of events 2 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
6.7%
2/30 • Number of events 2 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
General disorders
Asthenia
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
6.7%
2/30 • Number of events 2 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
General disorders
Fatigue
|
10.0%
3/30 • Number of events 3 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
General disorders
Hot flush
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
General disorders
Hyperhidrosis
|
20.0%
6/30 • Number of events 6 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Immune system disorders
Hypersensitivity
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Injury, poisoning and procedural complications
Application site pain
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Injury, poisoning and procedural complications
Eye burns
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Injury, poisoning and procedural complications
Muscle injury
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
2/30 • Number of events 2 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Metabolism and nutrition disorders
Increased appetite
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Metabolism and nutrition disorders
Oedema peripheral
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
3/30 • Number of events 6 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Nervous system disorders
Dizziness
|
10.0%
3/30 • Number of events 12 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Nervous system disorders
Headache
|
16.7%
5/30 • Number of events 10 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
6.7%
2/30 • Number of events 2 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Nervous system disorders
Hypoaesthesia
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Nervous system disorders
Vertigo
|
3.3%
1/30 • Number of events 2 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Psychiatric disorders
Anxiety
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Psychiatric disorders
Disturbance in attention
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Psychiatric disorders
Insomnia
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Psychiatric disorders
Restlessness
|
10.0%
3/30 • Number of events 3 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Psychiatric disorders
Sleep disorder
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Renal and urinary disorders
Cystitis
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
10.0%
3/30 • Number of events 4 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Skin and subcutaneous tissue disorders
Herpes simplex
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Skin and subcutaneous tissue disorders
Nail injury
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
2/30 • Number of events 2 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Surgical and medical procedures
Dental implantation
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/30 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
3.3%
1/30 • Number of events 1 • Treatment emergent adverse events were collected from baseline to D90. 90days. • Change from baseline to end of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place