History of Changes for Study: NCT03005288

Safety, Pharmacokinetics and Efficacy of Bimagrumab in Obese Patients With Type 2 Diabetes

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Study Record Versions

Version	Submitted Date	Changes
1	December 28, 2016	None (earliest Version on record)
2	February 19, 2017	Recruitment Status, Study Status, Arms and Interventions, Contacts/Locations and Eligibility
3	May 5, 2017	Outcome Measures, Study Status, Oversight, Contacts/Locations, Eligibility, Arms and Interventions, Study Identification, IPDSharing and Study Description
4	June 6, 2017	Study Status
5	November 15, 2017	Study Status, Outcome Measures, Contacts/Locations and Eligibility
6	April 5, 2018	Study Status, Contacts/Locations, Eligibility, Outcome Measures, Study Design and Oversight
7	July 17, 2018	Recruitment Status, Study Status, Contacts/Locations and Study Design
8	October 1, 2018	Study Status and Study Design
9	April 12, 2019	Study Status, Outcome Measures and Study Design
10	June 11, 2019	Recruitment Status, Study Status and Study Design
11	August 22, 2019	Study Status
12	August 28, 2019	Arms and Interventions and Study Status
13	April 14, 2020	Contacts/Locations and Study Status
14	May 7, 2020	Quality Control Review has not concluded Returned: May 27, 2020 Arms and Interventions, Contacts/Locations, Outcome Measures, Study Status, Study Description, Document Section, Adverse Events, Baseline Characteristics, Participant Flow, IPDSharing, Eligibility and Study Design
15	June 2, 2020	Study Status, Outcome Measures and Participant Flow
16	December 9, 2020	References and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CBYM338X2211
Brief Title:	Safety, Pharmacokinetics and Efficacy of Bimagrumab in Obese Patients With Type 2 Diabetes
Official Title:	A Randomized, Subject- and Investigator-blinded, Placebo Controlled Study to Assess the Safety, Pharmacokinetics and Efficacy of Intravenous Bimagrumab in Obese Patients With Type 2 Diabetes
Secondary IDs:

Study Status


Record Verification:	December 2016
Overall Status:	Not yet recruiting
Study Start:	December 2016
Primary Completion:	January 2019 [Anticipated]
Study Completion:	January 2019 [Anticipated]

First Submitted:	December 24, 2016
First Submitted that Met QC Criteria:	December 28, 2016
First Posted:	December 29, 2016 [Estimate]

Last Update Submitted that Met QC Criteria:	December 28, 2016
Last Update Posted:	December 29, 2016 [Estimate]

Sponsor/Collaborators


Sponsor:	Novartis Pharmaceuticals
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description


Brief Summary:	This study will assess the safety, pharmacokinetics and efficacy of bimagrumab when administered in obese patients with type 2 diabetes
Detailed Description:

Conditions


Conditions:	Diabetes Mellitus, Type 2
Keywords:	type 2 diabetes obesity DXA MRI

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	60 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: bimagrumab	Drug: bimagrumab
Placebo Comparator: placebo	Drug: placebo

Outcome Measures


Primary Outcome Measures:
1.	Change in fat body mass as measured by DXA [ Time Frame: Week 24 ]
2.	Change in fat body mass as measured by DXA [ Time Frame: Week 48 ]
Secondary Outcome Measures:
1.	Mean change from baseline in HbA1c, insulin resistance as measured by the homeostatic model assessment (HOMA-IR), fasting insulin and glucose [ Time Frame: Week 24 and Week 48 ] plasma samples are taken and insulin resistance is measured via the homeostatic model assessment using a computer to model insulin sensitivity. A model will be used to describe HbA1c over time and the change in HbA1c at Week 24 and Week 48 will be estimated from that model.
2.	Pharmacokinetics of bimagrumab: the observed minimum plasma concentration (Cmin) following drug administration [ Time Frame: Baseline, Day 84, 168, 252, 308. 336, 364, 392 ] Samples during treatment and follow up periods pre- and post-dose
3.	Change in body weight, BMI, waist circumference, waist-to-hip ratio and lean body mass as measured by DXA [ Time Frame: Baseline, Week 24, Week 48 ] change on anthropometric body measurements and lean body mass from baseline at Week 24 and Week 48
4.	Anti drug antibodies after repeat doses of bimagrumab [ Time Frame: Baseline, Day 168, 336, 392 ] The immunogenic response is measured during treatment and the follow up period in obse patients with type 2 diabetes
5.	Pharmacokinetics of bimagrumab: the observed maximum plasma concentration (Cmax) following drug administration [ Time Frame: Baseline, Day 84, 168, 252, 308. 336, 364, 392 ] Samples during treatment and follow up periods pre- and post-dose

Eligibility


Minimum Age:	18 Years
Maximum Age:	65 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Type 2 diabetes with HbA1c between 7% and 10% at screening with stable treatment for 3 months prior to randomization Body Mass Index of 28 to 40 kg/m2 at screening Body weight between 65 and 140 kg at screening Exclusion Criteria: Women of child-bearing potential unless they are using highly effective methods of contraception Diabetes other than Type 2 such as Type 1 diabetes, surgically induced diabetes, "brittle" type 2 diabetes as per investigator judgement, history of severe hypoglycemic episodes in the year preceding screening or hypoglycemic unawareness history of clincally significant arrythmias, unstable angina, myocardial infarction or stroke, coronary artery bypass graft surgery, or percutaneous coronary intervention within 6 months of screening or 1 year for drug-eluting stents use of anti-obesity medications, nutritional supplements or over the counter products ofr wieght loss within 3 months of screening use of medications known to induce weight gain such as some anti-convulsant and psychotropic medications within 3 months of screening Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc). uncontrolled thyroid disease. Stable euthyroid patinets on stable thyroid replacement therapy for at least 3 months of screening are allowed. Known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis) Uncontrolled depression Use of skeletal muscle anabolic agents in any form for 3 months prior to screening Chronic kidney disease [estimated glomerular filtration rate (GFR) < 30 mL/min];

Contacts/Locations


Central Contact Person:	Novartis Pharmaceuticals Telephone: 1-888-669-6682
Central Contact Backup:	Novartis Pharmaceuticals
Study Officials:	Thomas M. Wade, MD Principal Investigator QPS MRA LLC, Miami
Locations:

IPDSharing


Plan to Share IPD:	Undecided

References


Links:
Available IPD/Information: