Study of Subcutaneous Doses of HIP2B in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

NCT01933256 | Completed Phase 1

• 1 other identifier: TDU1156-002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; HIP2B; Placebo; islet β cell

Outcome Measures

Primary Outcomes (1)

• The safety and tolerability of repeat doses of HIP2B in subjects with type 2 diabetes mellitus.

  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.

  Adverse Events / vitals are monitored at each study visit between Days -9 and 84.

Secondary Outcomes (1)

• Glucose-stimulated insulin secretion.

  IVGTT performed on Day -8 and Day 49. GGI performed on Day -1, Day 25 and Day 46.

Other Outcomes (4)

• Pre-hepatic insulin secretion rate.

  GGI used for assessments is performed on Day -1, Day 25 and Day 46.

• Change in β-cell responsiveness.

  GGI measured on Day-1, Day 25 and Day 46.

• PK parameters of HIP2B after single and repetitive dosing.

  PK testing done on Day 1 and Day 46 at pre-dose, 15 and 30min, 1 and 2 hours post dose.

Study Arms (3)

600mg HIP2B

EXPERIMENTAL

600mg HIP2B

Drug: HIP2B

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

400mg HIP2B

EXPERIMENTAL

400mg HIP2B

Drug: HIP2B

Interventions

HIP2B DRUG

400mg HIP2B; 600mg HIP2B

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 30 to 65 years, inclusive
• Males and females
• Diagnosis of type 2 diabetes mellitus prior to screening meeting the following criteria:
• Body mass index \<45 kg/m2
• HbA1c value of \> 6.5 to \<9.5%
• C-peptide ≥1.0 ng/mL
• On a stable dose of metformin for 12 weeks
• Ability to provide written informed consent and be willing to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

You may not qualify if:

• History of any of the following: type 1 diabetes mellitus, diabetic ketoacidosis, an episode of severe hypoglycemia (defined as a change in mental status requiring assistance) during the prior 30 days
• FPG \>260 mg/dL at time of randomization
• Current or chronic use (within past 12 weeks) of insulin, or insulin secretagogues including: sulfonylureas, GLP-1 analogs, DPP-4 inhibitors, meglitinides, α-glucosidase inhibitors, pioglitazone, or rosiglitazone
• Glomerular filtration rate (GFR) \<60 as calculated using the Modified Diet in Renal Disease equation at screening
• ALT, AST or total bilirubin \> 2 X ULN
• Serum amylase concentration \> 1.5XULN or serum lipase concentration \>2XULN
• Positive test result for glutamic acid decarboxylase antibodies (GADA).
• The presence of a clinically significant abnormality on resting electrocardiogram (ECG)
• Positive HIV, hepatitis B (HBsAg), or positive hepatitis C (HCV Ab) test at screening
• History of clinically significant renal, hepatic, cardiovascular, neurological, or gastrointestinal disease that could impact patient safety in the investigator's opinion
• Serum triglycerides \>500 mg/dL
• Presence or history of cancer within the past 5 years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer
• History of weight loss \> 5% in the 8 weeks prior to randomization or subject is on a weight loss program and is not in the maintenance phase
• Use of any weight loss medication within 8 weeks of randomization
• Uncontrolled hypertension defined as blood pressure \>160/100 mmHg, using an appropriately sized cuff, at rest

Sponsors & Collaborators

• CureDM: lead
• Profil Institute for Clinical Research, Inc.: collaborator

Study Sites (1)

Profil Institute for Clinical Research, Inc.

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Marcus Hompesch, MD

  Profil Institute for Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: September 2, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

US (1)