Type 2 Diabetes MellitusPhase 1NCT01933256
Study of Subcutaneous Doses of HIP2B in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
A Phase 1 study testing HIP2B in people with Type 2 Diabetes Mellitus, run by CureDM at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- HIP2B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- History or evidence of multiple organ autoimmune disorders
- History of thyroid dysfunction other that hypothyroidism treated with stable dose of thyroid hormone and euthyroid at screening
- History or presence of acute or chronic pancreatitis or symptomatic recurrent gallstones
- Has undergone surgery within 6 months of screening or plans to undergo surgery during the study period
- Use of parenterally administered proteins or antibodies within 12 weeks of screening. (Note: Influenza vaccine will be allowed.)
- Prior exposure to any investigational agent or participation in an investigational trial within 30 days prior to Day 1
- Blood loss or blood donation >500 ml in the 2 months prior to screening.
- Use of systemic long-acting corticosteroids within two months or prolonged use (more than one week) of other systemic corticosteroids or inhaled corticosteroids (if daily dosage is >1000 mcg equivalent beclomethasone) within 30 days prior to screening visit.
- Drugs with the potential to affect (either increasing or decreasing) endogenous insulin secretion or insulin sensitivity including corticosteroids (as detailed above), β-adrenergic blockers, beta-adrenergic agonists, quinine, thiazide or thiazide-like diuretics, calcineurin inhibitors, niacin, anti-psychotic or antidepressant drugs, somatostatin analogs, growth hormone, weight-reducing drugs (e.g. orlistat, phentermine and topiramate extended-release, lorcaserin). Stable doses of agents commonly required by subjects with T2DM including angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, statins, fibrates, and aspirin (<100 mg daily) will be permitted at the discretion of the investigator.
- A serious adverse reaction or hypersensitivity to any drug, unless reaction deemed irrelevant to the study by the investigator and sponsor.
- History of alcohol abuse or drug abuse within the previous 12 months. No history of medical or recreational use of marijuana within previous 12 months.
- A history of smoking more than one-half a pack of cigarettes per day within last 12 months
- History of stroke, transient ischemic attack or myocardial infarction within 6 months prior to screening.
- History of New York Heart Association Class II-IV heart failure prior to screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911
About this study
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
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
- Being tested
- HIP2B, Placebo
- Keywords
- Type 2 Diabetes Mellitus, HIP2B, Placebo, islet β cell
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIP2BDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 600mg HIP2B | Experimental | 600mg HIP2B Receives: Drug: HIP2B |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| 400mg HIP2B | Experimental | 400mg HIP2B Receives: Drug: HIP2B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Adverse Events / vitals are monitored at each study visit between Days -9 and 84.
Secondary outcomes (1)
Glucose-stimulated insulin secretion.
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.
Measured: IVGTT performed on Day -8 and Day 49. GGI performed on Day -1, Day 25 and Day 46.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- CureDM
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Profil Institute for Clinical Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Marcus Hompesch, MD, Principal investigator, Profil Institute for Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933256
- Sponsor's protocol ID
- TDU1156-002
- Status last verified
- Nov 2016
- First submitted
- 5 Aug 2013
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01933256
- Acronym / sponsor ID
- TDU1156-002
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, HIP2B, Placebo, islet β cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CureDMIndustry (pharma, biotech, devices)
- Collaborators
- Profil Institute for Clinical Research, Inc.
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 600mg HIP2B | Experimental | Drug: HIP2B600mg HIP2B |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| 400mg HIP2B | Experimental | Drug: HIP2B400mg HIP2B |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 30 to 65 years, inclusive
- Males and females
- Diagnosis of type 2 diabetes mellitus prior to screening meeting the following criteria:
- Ability to provide written informed consent and be willing to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIP2B | Drug | 400mg HIP2B, 600mg HIP2B |
| Placebo | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
Glucose-stimulated insulin secretion.
Time frame: IVGTT performed on Day -8 and Day 49. GGI performed on Day -1, Day 25 and Day 46.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Hompesch, MD principal investigator
Profil Institute for Clinical Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HIP2B in people with Type 2 Diabetes Mellitus, run by CureDM at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.