BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus
Sponsor
Eisai Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00603291
Collaborator
(none)
604
1
3
34
17.8
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral hypoglycemic agents.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
604 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients With Type 2 Diabetes Mellitus Managed With Oral Hypoglycemic Agent(s)
Study Start Date
:
Dec 1, 2007
Actual Primary Completion Date
:
Jun 1, 2010
Actual Study Completion Date
:
Oct 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lorcaserin 10 mg QD Lorcaserin 10 mg tablet each morning and placebo tablet each evening |
Drug: Lorcaserin 10 mg once daily (QD)
Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
Other Names:
|
| Experimental: Lorcaserin 10 mg BID Lorcaserin 10 mg tablet each morning and evening |
Drug: Lorcaserin 10 mg twice a day (BID)
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
Other Names:
|
| Placebo Comparator: Matching Placebo Matching placebo tablet each morning and evening |
Drug: Matching Placebo
Matching placebo tablet each morning and evening for a duration of 52 weeks.
|
Outcome Measures
Primary Outcome Measures
- Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 [Baseline and Week 52]
The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.
Secondary Outcome Measures
- Percent Change in Body Weight From Baseline to Week 52 [Baseline and Week 52]
The percent change in body weight (kg) from baseline to week 52.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Overweight/obese men and women with type 2 diabetes mellitus that is managed with oral anti-hyperglycemic agent(s).
-
Body mass index (BMI) 27 to 45 kg/m2, inclusive.
-
Ability to complete a 1 year study
Exclusion Criteria:
-
Pregnancy
-
Use of insulin in any form, exenatide (Byetta) or pramlintide (Symlin) within 3 months prior to screening
-
History of symptomatic heart valve disease
-
Serious or unstable current or past medical conditions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arena Pharmaceuticals, Inc. | San Diego | California | United States | 92121 |
Sponsors and Collaborators
- Eisai Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00603291
Other Study ID Numbers:
- APD356-010
First Posted:
Jan 29, 2008
Last Update Posted:
Oct 2, 2019
Last Verified:
Aug 1, 2019
Keywords provided by Eisai Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Lorcaserin 10 mg Once Daily (QD) | Lorcaserin 10 mg Twice a Day (BID) | Matching Placebo |
|---|---|---|---|
| Arm/Group Description | lorcaserin 10 mg QD tablets | lorcaserin 10 mg BID tablets | matching placebo tablets |
| Period Title: Overall Study | |||
| STARTED | 95 | 256 | 253 |
| COMPLETED | 75 | 169 | 157 |
| NOT COMPLETED | 20 | 87 | 96 |
Baseline Characteristics
| Arm/Group Title | Lorcaserin 10 mg QD | Lorcaserin 10 mg BID | Matching Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | lorcaserin 10 mg QD tablets | lorcaserin 10 mg BID tablets | matching placebo tablets | Total of all reporting groups |
| Overall Participants | 95 | 256 | 252 | 603 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
53.1
(7.98)
|
53.2
(8.26)
|
52.0
(9.32)
|
52.7
(8.68)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
53
55.8%
|
137
53.5%
|
137
54.4%
|
327
54.2%
|
| Male |
42
44.2%
|
119
46.5%
|
115
45.6%
|
276
45.8%
|
Outcome Measures
| Title | Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 |
|---|---|
| Description | The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks. |
| Time Frame | Baseline and Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent to Treat (MITT) with last observation carried forward (LOCF) |
| Arm/Group Title | Lorcaserin 10 mg BID | Lorcaserin 10 mg QD | Matching Placebo |
|---|---|---|---|
| Arm/Group Description | lorcaserin 10 mg BID tablets | lorcaserin 10 mg QD tablets | matching placebo tablets |
| Measure Participants | 251 | 94 | 248 |
| Number [percentage of participants] |
37.5
39.5%
|
44.7
17.5%
|
16.1
6.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Lorcaserin 10 mg BID, Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Adjustment for baseline body weight, baseline HbA1c stratum, and prior antihyperglycemic medication stratum | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 3.14 | |
| Confidence Interval |
(2-Sided) 95% 2.05 to 4.80 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change in Body Weight From Baseline to Week 52 |
|---|---|
| Description | The percent change in body weight (kg) from baseline to week 52. |
| Time Frame | Baseline and Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| MITT with LOCF |
| Arm/Group Title | Lorcaserin 10 mg BID | Lorcaserin 10 mg QD | Matching Placebo |
|---|---|---|---|
| Arm/Group Description | lorcaserin 10 mg BID tablets | lorcaserin 10 mg QD tablets | matching placebo tablets |
| Measure Participants | 251 | 94 | 248 |
| Least Squares Mean (Standard Error) [% change from baseline: body wt (kg)] |
-4.54
(0.35)
|
-4.97
(0.54)
|
-1.48
(0.36)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Lorcaserin 10 mg BID, Matching Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.06 | |
| Confidence Interval |
(2-Sided) 95% -3.92 to -2.20 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | 52 weeks | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Lorcaserin 10 mg BID | Lorcaserin 10 mg QD | Matching Placebo | |||
| Arm/Group Description | lorcaserin 10 mg BID tablets | lorcaserin 10 mg QD tablets | matching placebo tablets | |||
All Cause Mortality |
||||||
| Lorcaserin 10 mg BID | Lorcaserin 10 mg QD | Matching Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Lorcaserin 10 mg BID | Lorcaserin 10 mg QD | Matching Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/256 (6.3%) | 8/95 (8.4%) | 17/252 (6.7%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/256 (0%) | 0 | 1/95 (1.1%) | 1 | 0/252 (0%) | 0 |
| Cardiac disorders | ||||||
| Coronary artery occlusion | 1/256 (0.4%) | 1 | 0/95 (0%) | 0 | 0/252 (0%) | 0 |
| Coronary artery disease | 0/256 (0%) | 0 | 1/95 (1.1%) | 1 | 0/252 (0%) | 0 |
| Angina pectoris | 0/256 (0%) | 0 | 1/95 (1.1%) | 1 | 0/252 (0%) | 0 |
| Myocardial infarction | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 2/252 (0.8%) | 2 |
| Atrial fibrillation | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 1 |
| Gastrointestinal disorders | ||||||
| Gastrointestinal ulcer haemorrhage | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 1 |
| Colitis | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 1 |
| Pancreatitis acute | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 1 |
| General disorders | ||||||
| Non-cardiac chest pain | 2/256 (0.8%) | 2 | 0/95 (0%) | 0 | 1/252 (0.4%) | 1 |
| Adverse drug reaction | 1/256 (0.4%) | 1 | 0/95 (0%) | 0 | 0/252 (0%) | 0 |
| Chest pain | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 2/252 (0.8%) | 2 |
| Hepatobiliary disorders | ||||||
| Cholecystitis | 1/256 (0.4%) | 1 | 0/95 (0%) | 0 | 0/252 (0%) | 0 |
| Immune system disorders | ||||||
| Anaphylactic shock | 1/256 (0.4%) | 1 | 0/95 (0%) | 0 | 0/252 (0%) | 0 |
| Hypersensitivity | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 1 |
| Infections and infestations | ||||||
| Abdominal abscess | 1/256 (0.4%) | 1 | 0/95 (0%) | 0 | 0/252 (0%) | 0 |
| Gastroenteritis | 2/256 (0.8%) | 2 | 0/95 (0%) | 0 | 0/252 (0%) | 0 |
| Infected skin ulcer | 0/256 (0%) | 0 | 1/95 (1.1%) | 1 | 0/252 (0%) | 0 |
| Cellulitis of male external genital organ | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 1 |
| Cellulitis | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 2/252 (0.8%) | 2 |
| Bursitis infective | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 1 |
| Metabolism and nutrition disorders | ||||||
| Dehydration | 1/256 (0.4%) | 1 | 0/95 (0%) | 0 | 0/252 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Osteoarthritis | 1/256 (0.4%) | 1 | 0/95 (0%) | 0 | 0/252 (0%) | 0 |
| Back pain | 1/256 (0.4%) | 1 | 0/95 (0%) | 0 | 0/252 (0%) | 0 |
| Intervertebral disc protrusion | 1/256 (0.4%) | 1 | 0/95 (0%) | 0 | 0/252 (0%) | 0 |
| Spinal column stenosis | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Uterine leiomyoma | 1/256 (0.4%) | 1 | 0/95 (0%) | 0 | 0/252 (0%) | 0 |
| Thymoma | 1/256 (0.4%) | 1 | 0/95 (0%) | 0 | 0/252 (0%) | 0 |
| Prostate cancer | 0/256 (0%) | 0 | 1/95 (1.1%) | 1 | 0/252 (0%) | 0 |
| Urethral cancer | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 1 |
| Oesophageal carcinoma | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 1 |
| Endometrial cancer | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 1 |
| Nervous system disorders | ||||||
| Cerebrovascular accident | 0/256 (0%) | 0 | 2/95 (2.1%) | 2 | 0/252 (0%) | 0 |
| Convulsion | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 2 |
| Psychiatric disorders | ||||||
| Conversion disorder | 1/256 (0.4%) | 1 | 0/95 (0%) | 0 | 0/252 (0%) | 0 |
| Depression | 0/256 (0%) | 0 | 1/95 (1.1%) | 1 | 0/252 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Nephrolithiasis | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 2 |
| Acute prerenal failure | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Asthma | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 1 |
| Vascular disorders | ||||||
| Hypotension | 1/256 (0.4%) | 1 | 0/95 (0%) | 0 | 0/252 (0%) | 0 |
| Phlebitis | 0/256 (0%) | 0 | 0/95 (0%) | 0 | 1/252 (0.4%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| Lorcaserin 10 mg BID | Lorcaserin 10 mg QD | Matching Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 236/256 (92.2%) | 89/95 (93.7%) | 213/252 (84.5%) | |||
| Gastrointestinal disorders | ||||||
| Nausea | 24/256 (9.4%) | 26 | 8/95 (8.4%) | 8 | 20/252 (7.9%) | 27 |
| Diarrhoea | 19/256 (7.4%) | 19 | 13/95 (13.7%) | 16 | 19/252 (7.5%) | 23 |
| Constipation | 11/256 (4.3%) | 11 | 6/95 (6.3%) | 8 | 12/252 (4.8%) | 14 |
| General disorders | ||||||
| Fatigue | 19/256 (7.4%) | 19 | 5/95 (5.3%) | 5 | 10/252 (4%) | 11 |
| Infections and infestations | ||||||
| Upper respiratory tract infection | 35/256 (13.7%) | 46 | 19/95 (20%) | 23 | 37/252 (14.7%) | 46 |
| Nasopharyngitis | 29/256 (11.3%) | 37 | 22/95 (23.2%) | 28 | 25/252 (9.9%) | 29 |
| Urinary tract infection | 23/256 (9%) | 25 | 9/95 (9.5%) | 12 | 15/252 (6%) | 16 |
| Gastroenteritis viral | 18/256 (7%) | 19 | 5/95 (5.3%) | 6 | 11/252 (4.4%) | 14 |
| Influenza | 15/256 (5.9%) | 16 | 8/95 (8.4%) | 9 | 13/252 (5.2%) | 14 |
| Sinusitis | 16/256 (6.3%) | 18 | 5/95 (5.3%) | 6 | 26/252 (10.3%) | 29 |
| Bronchitis | 8/256 (3.1%) | 8 | 5/95 (5.3%) | 6 | 11/252 (4.4%) | 11 |
| Gastroenteritis | 8/256 (3.1%) | 8 | 5/95 (5.3%) | 5 | 5/252 (2%) | 6 |
| Injury, poisoning and procedural complications | ||||||
| Procedural pain | 13/256 (5.1%) | 13 | 0/95 (0%) | 0 | 5/252 (2%) | 5 |
| Metabolism and nutrition disorders | ||||||
| Hypoglycemia | 75/256 (29.3%) | 513 | 32/95 (33.7%) | 253 | 53/252 (21%) | 321 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 15/256 (5.9%) | 15 | 10/95 (10.5%) | 12 | 19/252 (7.5%) | 21 |
| Pain in extremity | 13/256 (5.1%) | 13 | 5/95 (5.3%) | 5 | 17/252 (6.7%) | 19 |
| Back pain | 30/256 (11.7%) | 33 | 8/95 (8.4%) | 10 | 20/252 (7.9%) | 21 |
| Nervous system disorders | ||||||
| Headache | 37/256 (14.5%) | 48 | 16/95 (16.8%) | 20 | 18/252 (7.1%) | 24 |
| Dizziness | 18/256 (7%) | 21 | 11/95 (11.6%) | 14 | 16/252 (6.3%) | 20 |
| Psychiatric disorders | ||||||
| Depression | 6/256 (2.3%) | 6 | 5/95 (5.3%) | 6 | 5/252 (2%) | 5 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 21/256 (8.2%) | 23 | 5/95 (5.3%) | 5 | 11/252 (4.4%) | 11 |
| Sinus congestion | 9/256 (3.5%) | 9 | 5/95 (5.3%) | 5 | 12/252 (4.8%) | 12 |
| Vascular disorders | ||||||
| Hypertension | 13/256 (5.1%) | 14 | 6/95 (6.3%) | 8 | 8/252 (3.2%) | 9 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Eisai Medical Information |
|---|---|
| Organization | Eisai Inc. |
| Phone | +1-888-274-2378 |
| esi_medinfo@eisai.com |
Responsible Party:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00603291
Other Study ID Numbers:
- APD356-010
First Posted:
Jan 29, 2008
Last Update Posted:
Oct 2, 2019
Last Verified:
Aug 1, 2019