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Study of Subcutaneous Doses of HIP2B in Subjects With Type 2 Diabetes Mellitus Treated With Metformin | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT01933256•CureDM

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults aged 30 to 65 years, inclusive
•Males and females
•Diagnosis of type 2 diabetes mellitus prior to screening meeting the following criteria:
•1. Body mass index \<45 kg/m2
•2. HbA1c value of \> 6.5 to \<9.5%
•3. C-peptide ≥1.0 ng/mL
•4. 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

Exclusion Criteria

•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
+19 more criteria

Locations (1)

Profil Institute for Clinical Research, Inc.

Chula Vista, California, United States

Key Dates

Start Date

August 1, 2013

Primary Completion Date

September 1, 2014

Completion Date

December 1, 2014

Last Updated

November 15, 2016

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

HIP2B

DRUG

Placebo

DRUG

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NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

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Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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