Study of Subcutaneous Doses of HIP2B in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
|ClinicalTrials.gov Identifier: NCT01933256|
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : November 15, 2016
HIP2B is being developed for the treatment of type 1 and type 2 diabetes mellitus.
The purpose of this study is to investigate the safety and tolerability of repeat doses of HIP2B in subjects with type 2 diabetes mellitus. The study will also assess whether islet β-cell number and function will increase over time in response to repeat HIP2B injections.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: HIP2B Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||A Randomized, Double-blind, Placebo-controlled Study of the Effect of 49 Days of Treatment With Repeated Subcutaneous Doses of HIP2B to Assess Safety, Tolerability and Measures of Islet β-cell Function in Subjects With Type 2 Diabetes Mellitus Treated With Metformin|
|Study Start Date :||August 2013|
|Primary Completion Date :||September 2014|
|Study Completion Date :||December 2014|
Experimental: 600mg HIP2B
Placebo Comparator: Placebo
Experimental: 400mg HIP2B
- The safety and tolerability of repeat doses of HIP2B in subjects with type 2 diabetes mellitus. [ Time Frame: Adverse Events / vitals are monitored at each study visit between Days -9 and 84. ]Safety evaluations will include clinical observation and adverse event (AE) reporting; evaluation of the injection site, physical examination, vital signs; electrocardiograms (ECGs), hematology, chemistry panels (inclusive of expanded markers of liver function), dipstick urinalysis (microscopic evaluation if dipstick positive), amylase, LDH.
- Glucose-stimulated insulin secretion. [ Time Frame: IVGTT performed on Day -8 and Day 49. GGI performed on Day -1, Day 25 and Day 46. ]First-phase insulin response will be assessed (a) as the incremental insulin peak (above baseline) after glucose injection during the IVGTT and (b) as the incremental insulin area obtained over 10 min; incremental area under the curve (AUC) during the GGI will be calculated for insulin and C-peptide.
- Pre-hepatic insulin secretion rate. [ Time Frame: GGI used for assessments is performed on Day -1, Day 25 and Day 46. ]The pre-hepatic insulin secretion rate will be calculated based on deconvolution of peripheral C-peptide concentrations during GGI using the method described by Hovorka et al.
- Change in β-cell responsiveness. [ Time Frame: GGI measured on Day-1, Day 25 and Day 46. ]Change in β-cell responsiveness will be assessed by comparing the slopes of the change of plasma insulin against glucose before and after treatment.
- PK parameters of HIP2B after single and repetitive dosing. [ Time Frame: PK testing done on Day 1 and Day 46 at pre-dose, 15 and 30min, 1 and 2 hours post dose. ]PK parameters of HIP2B: e.g. Cmax, Tmax, AUC (0.t), AUC(0-∞), CL/F, V/F, t½.
- Pharmacodynamic (PD) effects of repeat doses of HIP2B on measures of glycemic control and β-cell function [ Time Frame: Assessments completed at screening, Days -9, -8, -2, -1, 1, 7, 14, 21, 24, 28, 42, 45, 46, 48, 49, 61, 68, and 84. ]Pharmacodynamic (PD) effects of repeat doses of HIP2B on measures of glycemic control and β-cell function including fasting plasma glucose, fasting C-peptide, fasting proinsulin/insulin ratio and HOMA-B; glycated albumin, HbA1c, and 7-point glucose profiles.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933256
|United States, California|
|Profil Institute for Clinical Research, Inc.|
|Chula Vista, California, United States, 91911|
|Principal Investigator:||Marcus Hompesch, MD||Profil Institute for Clinical Research, Inc.|