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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01943045




Registration number
NCT01943045
Ethics application status
Date submitted
11/09/2013
Date registered
16/09/2013
Date last updated
17/11/2015

Titles & IDs
Public title
Phase 2 Study of NGM282 in Patients With Type 2 Diabetes
Scientific title
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Activity of NGM282 Administered for 28 Days to Patients With Type 2 Diabetes Mellitus
Secondary ID [1] 0 0
13-0102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: NGM282 Dose 1 - NGM Dose 1

Experimental: NGM282 Dose 2 - NGM Dose 2

Experimental: NGM282 Dose 3 - NGM Dose 3

Placebo comparator: Placebo - Placebo
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fasting Plasma Glucose
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
HbA1c
Timepoint [1] 0 0
28 days
Secondary outcome [2] 0 0
Lipids
Timepoint [2] 0 0
28 days

Eligibility
Key inclusion criteria
* Males or females, between 18 and 70 years of age, inclusive
* BMI range of 24-40 kg/m2, inclusive
* No active coronary artery disease
* Resting heart rate in the range of 40-100 bpm
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of Type 1 diabetes
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
NGM Clinical Study Site 6103 - Melbourne
Recruitment hospital [2] 0 0
NGM Clinical Study Site 6104 - Melbourne
Recruitment hospital [3] 0 0
NGM Clinical Study Site 6101 - Perth
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Dunedin
Country [4] 0 0
New Zealand
State/province [4] 0 0
Tauranga
Country [5] 0 0
New Zealand
State/province [5] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
NGM Biopharmaceuticals, Inc
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
NGM Biopharmaceuticals Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Type 2 Diabetes.
Trial website
https://clinicaltrials.gov/study/NCT01943045
Trial related presentations / publications
DePaoli AM, Zhou M, Kaplan DD, Hunt SC, Adams TD, Learned RM, Tian H, Ling L. FGF19 Analog as a Surgical Factor Mimetic That Contributes to Metabolic Effects Beyond Glucose Homeostasis. Diabetes. 2019 Jun;68(6):1315-1328. doi: 10.2337/db18-1305. Epub 2019 Mar 12.
Public notes

Contacts
Principal investigator
Name 0 0
Alex M DePaoli, MD
Address 0 0
NGM Biopharmaceuticals, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01943045