Trial Outcomes & Findings for BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus (NCT NCT00603291)
NCT ID: NCT00603291
Last Updated: 2019-10-02
Results Overview
The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
604 participants
Primary outcome timeframe
Baseline and Week 52
Results posted on
2019-10-02
Participant Flow
Participant milestones
| Measure |
Lorcaserin 10 mg Once Daily (QD)
lorcaserin 10 mg QD tablets
|
Lorcaserin 10 mg Twice a Day (BID)
lorcaserin 10 mg BID tablets
|
Matching Placebo
matching placebo tablets
|
|---|---|---|---|
|
Overall Study
STARTED
|
95
|
256
|
253
|
|
Overall Study
COMPLETED
|
75
|
169
|
157
|
|
Overall Study
NOT COMPLETED
|
20
|
87
|
96
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Lorcaserin 10 mg QD
n=95 Participants
lorcaserin 10 mg QD tablets
|
Lorcaserin 10 mg BID
n=256 Participants
lorcaserin 10 mg BID tablets
|
Matching Placebo
n=252 Participants
matching placebo tablets
|
Total
n=603 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 7.98 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 8.26 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 9.32 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 8.68 • n=4 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
327 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
276 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: Modified Intent to Treat (MITT) with last observation carried forward (LOCF)
The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.
Outcome measures
| Measure |
Lorcaserin 10 mg BID
n=251 Participants
lorcaserin 10 mg BID tablets
|
Lorcaserin 10 mg QD
n=94 Participants
lorcaserin 10 mg QD tablets
|
Matching Placebo
n=248 Participants
matching placebo tablets
|
|---|---|---|---|
|
Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52
|
37.5 percentage of participants
|
44.7 percentage of participants
|
16.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: MITT with LOCF
The percent change in body weight (kg) from baseline to week 52.
Outcome measures
| Measure |
Lorcaserin 10 mg BID
n=251 Participants
lorcaserin 10 mg BID tablets
|
Lorcaserin 10 mg QD
n=94 Participants
lorcaserin 10 mg QD tablets
|
Matching Placebo
n=248 Participants
matching placebo tablets
|
|---|---|---|---|
|
Percent Change in Body Weight From Baseline to Week 52
|
-4.54 % change from baseline: body wt (kg)
Standard Error 0.35
|
-4.97 % change from baseline: body wt (kg)
Standard Error 0.54
|
-1.48 % change from baseline: body wt (kg)
Standard Error 0.36
|
Adverse Events
Lorcaserin 10 mg BID
Serious events: 16 serious events
Other events: 236 other events
Deaths: 0 deaths
Lorcaserin 10 mg QD
Serious events: 8 serious events
Other events: 89 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 17 serious events
Other events: 213 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lorcaserin 10 mg BID
n=256 participants at risk
lorcaserin 10 mg BID tablets
|
Lorcaserin 10 mg QD
n=95 participants at risk
lorcaserin 10 mg QD tablets
|
Matching Placebo
n=252 participants at risk
matching placebo tablets
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 1 • 52 weeks
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 1 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.39%
1/256 • Number of events 1 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.39%
1/256 • Number of events 1 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Infections and infestations
Abdominal abscess
|
0.39%
1/256 • Number of events 1 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.78%
2/256 • Number of events 2 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Coronary artery occlusion
|
0.39%
1/256 • Number of events 1 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Vascular disorders
Hypotension
|
0.39%
1/256 • Number of events 1 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.39%
1/256 • Number of events 1 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.78%
2/256 • Number of events 2 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Psychiatric disorders
Conversion disorder
|
0.39%
1/256 • Number of events 1 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.39%
1/256 • Number of events 1 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.39%
1/256 • Number of events 1 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Immune system disorders
Anaphylactic shock
|
0.39%
1/256 • Number of events 1 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.39%
1/256 • Number of events 1 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.39%
1/256 • Number of events 1 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
General disorders
Adverse drug reaction
|
0.39%
1/256 • Number of events 1 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/256 • 52 weeks
|
1.1%
1/95 • Number of events 1 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/256 • 52 weeks
|
1.1%
1/95 • Number of events 1 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/256 • 52 weeks
|
1.1%
1/95 • Number of events 1 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/256 • 52 weeks
|
1.1%
1/95 • Number of events 1 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/256 • 52 weeks
|
1.1%
1/95 • Number of events 1 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/256 • 52 weeks
|
1.1%
1/95 • Number of events 1 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/256 • 52 weeks
|
2.1%
2/95 • Number of events 2 • 52 weeks
|
0.00%
0/252 • 52 weeks
|
|
Vascular disorders
Phlebitis
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 1 • 52 weeks
|
|
General disorders
Chest pain
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.79%
2/252 • Number of events 2 • 52 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 2 • 52 weeks
|
|
Nervous system disorders
Convulsion
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 2 • 52 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.79%
2/252 • Number of events 2 • 52 weeks
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 1 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urethral cancer
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 1 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.79%
2/252 • Number of events 2 • 52 weeks
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 1 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/256 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
0.40%
1/252 • Number of events 1 • 52 weeks
|
Other adverse events
| Measure |
Lorcaserin 10 mg BID
n=256 participants at risk
lorcaserin 10 mg BID tablets
|
Lorcaserin 10 mg QD
n=95 participants at risk
lorcaserin 10 mg QD tablets
|
Matching Placebo
n=252 participants at risk
matching placebo tablets
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
9.4%
24/256 • Number of events 26 • 52 weeks
|
8.4%
8/95 • Number of events 8 • 52 weeks
|
7.9%
20/252 • Number of events 27 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
19/256 • Number of events 19 • 52 weeks
|
13.7%
13/95 • Number of events 16 • 52 weeks
|
7.5%
19/252 • Number of events 23 • 52 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.3%
11/256 • Number of events 11 • 52 weeks
|
6.3%
6/95 • Number of events 8 • 52 weeks
|
4.8%
12/252 • Number of events 14 • 52 weeks
|
|
General disorders
Fatigue
|
7.4%
19/256 • Number of events 19 • 52 weeks
|
5.3%
5/95 • Number of events 5 • 52 weeks
|
4.0%
10/252 • Number of events 11 • 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
13.7%
35/256 • Number of events 46 • 52 weeks
|
20.0%
19/95 • Number of events 23 • 52 weeks
|
14.7%
37/252 • Number of events 46 • 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
11.3%
29/256 • Number of events 37 • 52 weeks
|
23.2%
22/95 • Number of events 28 • 52 weeks
|
9.9%
25/252 • Number of events 29 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
9.0%
23/256 • Number of events 25 • 52 weeks
|
9.5%
9/95 • Number of events 12 • 52 weeks
|
6.0%
15/252 • Number of events 16 • 52 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
7.0%
18/256 • Number of events 19 • 52 weeks
|
5.3%
5/95 • Number of events 6 • 52 weeks
|
4.4%
11/252 • Number of events 14 • 52 weeks
|
|
Infections and infestations
Influenza
|
5.9%
15/256 • Number of events 16 • 52 weeks
|
8.4%
8/95 • Number of events 9 • 52 weeks
|
5.2%
13/252 • Number of events 14 • 52 weeks
|
|
Infections and infestations
Sinusitis
|
6.2%
16/256 • Number of events 18 • 52 weeks
|
5.3%
5/95 • Number of events 6 • 52 weeks
|
10.3%
26/252 • Number of events 29 • 52 weeks
|
|
Infections and infestations
Bronchitis
|
3.1%
8/256 • Number of events 8 • 52 weeks
|
5.3%
5/95 • Number of events 6 • 52 weeks
|
4.4%
11/252 • Number of events 11 • 52 weeks
|
|
Infections and infestations
Gastroenteritis
|
3.1%
8/256 • Number of events 8 • 52 weeks
|
5.3%
5/95 • Number of events 5 • 52 weeks
|
2.0%
5/252 • Number of events 6 • 52 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.1%
13/256 • Number of events 13 • 52 weeks
|
0.00%
0/95 • 52 weeks
|
2.0%
5/252 • Number of events 5 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
29.3%
75/256 • Number of events 513 • 52 weeks
|
33.7%
32/95 • Number of events 253 • 52 weeks
|
21.0%
53/252 • Number of events 321 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
15/256 • Number of events 15 • 52 weeks
|
10.5%
10/95 • Number of events 12 • 52 weeks
|
7.5%
19/252 • Number of events 21 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
13/256 • Number of events 13 • 52 weeks
|
5.3%
5/95 • Number of events 5 • 52 weeks
|
6.7%
17/252 • Number of events 19 • 52 weeks
|
|
Nervous system disorders
Headache
|
14.5%
37/256 • Number of events 48 • 52 weeks
|
16.8%
16/95 • Number of events 20 • 52 weeks
|
7.1%
18/252 • Number of events 24 • 52 weeks
|
|
Nervous system disorders
Dizziness
|
7.0%
18/256 • Number of events 21 • 52 weeks
|
11.6%
11/95 • Number of events 14 • 52 weeks
|
6.3%
16/252 • Number of events 20 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.2%
21/256 • Number of events 23 • 52 weeks
|
5.3%
5/95 • Number of events 5 • 52 weeks
|
4.4%
11/252 • Number of events 11 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.5%
9/256 • Number of events 9 • 52 weeks
|
5.3%
5/95 • Number of events 5 • 52 weeks
|
4.8%
12/252 • Number of events 12 • 52 weeks
|
|
Vascular disorders
Hypertension
|
5.1%
13/256 • Number of events 14 • 52 weeks
|
6.3%
6/95 • Number of events 8 • 52 weeks
|
3.2%
8/252 • Number of events 9 • 52 weeks
|
|
Psychiatric disorders
Depression
|
2.3%
6/256 • Number of events 6 • 52 weeks
|
5.3%
5/95 • Number of events 6 • 52 weeks
|
2.0%
5/252 • Number of events 5 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.7%
30/256 • Number of events 33 • 52 weeks
|
8.4%
8/95 • Number of events 10 • 52 weeks
|
7.9%
20/252 • Number of events 21 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place