Safety, Pharmacokinetics and Efficacy of Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes
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| ClinicalTrials.gov Identifier: NCT03005288 |
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Recruitment Status :
Completed
First Posted : December 29, 2016
Results First Posted : June 4, 2020
Last Update Posted : January 5, 2021
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Diabetes Mellitus, Type 2 |
| Interventions |
Drug: BYM338 10 mg/kg Other: Placebo |
| Enrollment | 78 |
Participant Flow
| Recruitment Details | The study was completed as planned. |
| Pre-assignment Details | Participants were randomized to the study at 1:1 ratio to receive BYM338 10 mg/kg or placebo. |
| Arm/Group Title | BYM338 10 mg/kg | Placebo |
|---|---|---|
 Arm/Group Description |
intravenous infusion every four weeks | intravenous infusion every four weeks |
| Period Title: Overall Study | ||
| Started [1] | 39 | 39 |
| Safety Analysis Set [2] | 37 | 38 |
| Pharmacokinetics (PK) Analysis Set [3] | 36 [4] | 0 [5] |
| Pharmacodynamics (PD) Analysis Set [3] | 36 [4] | 36 [6] |
| Completed | 27 | 31 |
| Not Completed | 12 | 8 |
| Reason Not Completed | ||
| Withdrawal by Subject | 7 | 5 |
| Lost to Follow-up | 0 | 1 |
| Adverse Event | 5 | 0 |
| Protocol deviation | 0 | 1 |
| Physician Decision | 0 | 1 |
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[1]
All the participants who were assigned a randomization number.
[2]
All subjects that received any study drug.
[3]
All subjects who received any study drug and experienced no protocol deviations.
[4]
One subject was excluded due to a protocol deviation.
[5]
PK samples were only obtained and evaluated for subjects treated with BYM338.
[6]
Two subjects were excluded due to protocol deviations.
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Baseline Characteristics
| Arm/Group Title | BYM338 10 mg/kg | Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
intravenous infusion every four weeks | intravenous infusion every four weeks | Total of all reporting groups | |
| Overall Number of Baseline Participants | 37 | 38 | 75 | |
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Baseline Analysis Population Description |
A total of 78 participants were randomized and were assigned to the respective treatment groups. Of the 78 participants, 3 withdrew from the study prior to dosing due to subject/physician decision. The remaining 75 participants underwent baseline assessments and treatment analysis.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 37 participants | 38 participants | 75 participants | |
| 60.7 (7.50) | 60.2 (8.02) | 60.4 (7.72) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 37 participants | 38 participants | 75 participants | |
| Female |
23 62.2%
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12 31.6%
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35 46.7%
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| Male |
14 37.8%
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26 68.4%
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40 53.3%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Race | Number Analyzed | 37 participants | 38 participants | 75 participants |
| Black Or African American |
6 16.2%
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9 23.7%
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15 20.0%
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| Other |
1 2.7%
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0 0.0%
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1 1.3%
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| White |
30 81.1%
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27 71.1%
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57 76.0%
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| Asian |
0 0.0%
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1 2.6%
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1 1.3%
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| Unknown |
0 0.0%
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1 2.6%
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1 1.3%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Ethnicity | Number Analyzed | 37 participants | 38 participants | 75 participants |
| Hispanic Or Latino |
27 73.0%
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25 65.8%
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52 69.3%
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| Not Hispanic Or Latino |
9 24.3%
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12 31.6%
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21 28.0%
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| Not Reported |
1 2.7%
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1 2.6%
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2 2.7%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Novartis Pharmaceuticals |
| Phone: | 862-778-8300 |
| EMail: | Novartis.email@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT03005288 |
| Other Study ID Numbers: |
CBYM338X2211 |
| First Submitted: | December 24, 2016 |
| First Posted: | December 29, 2016 |
| Results First Submitted: | May 7, 2020 |
| Results First Posted: | June 4, 2020 |
| Last Update Posted: | January 5, 2021 |