Diabetes Mellitus, Type IIPhase 2NCT00501592
Study of INT-747 in Patients With Diabetes and Presumed NAFLD
A Phase 2 study testing INT-747 in people with Diabetes Mellitus, Type II and Fatty Liver, run by Intercept Pharmaceuticals at 4 sites in United States.
Trial summary
The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following: The safety and tolerability of multiple doses of INT 747; The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and glucose… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type II, Fatty Liver
- What is being tested?
- INT-747
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2007to Apr 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes, defined by the American Diabetes Association (ADA), as one of the following criteria:
- Symptoms of diabetes plus casual plasma glucose concentration >200 mg/dL (11.1 mmol/L) or
- Fasting plasma glucose >126 mg/dL (7.0 mmol/L) or
- 2-hour post-load glucose >200 mg/dL (11.1 mmol/L) during a 75 g oral glucose tolerance test (GTT).
- Presumed NAFLD, defined by one of the following criteria:
- Alanine aminotransferase (ALT) ≥47 U/L for females and ≥56 U/L for males
Show all 9Show fewer
- Aspartate aminotransferase (AST) ≥47 U/L for females and ≥60 U/L for males
- Enlarged liver (demonstrated by ultrasound or other imaging technique)
- Diagnostic histological findings shown on prior biopsy (in the last 5 years).
Who cannot join
- Bilirubin >2 × ULN
- ALT >155 U/L for females and >185 U/L for males.
- AST >155 U/L for females and >200 U/L for males.
- Patients taking any antidiabetic medications, with the exception of metformin and sulfonylureas. If the HbA1c is <11%, patients may be enrolled who have been withdrawn from all other diabetic medications as specified in the protocol, at the discretion of the Principal Investigator.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911
Virginia Commonwelath University
Richmond, Virginia, 23298
Diabetes & Glandular Disease Research Associates, Inc.
San Antonio, Texas, 78229
UC San Diego VAMC
San Diego, California, 92161
About this study
Official title: An Exploratory Study of INT-747 in Patients With Type 2 Diabetes Mellitus and Presumed Nonalcoholic Fatty Liver Disease
The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following:
- The safety and tolerability of multiple doses of INT 747;
- The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and glucose homeostasis;
- Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function and inflammation, and;
- Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic acid (6-EDCA) and tauro 6-ECDCA.
Read the detailed description
This is a multi-center, double-blind, randomized, placebo-controlled, multiple-dose, parallel-group study. Three (3) cohorts of 12 patients each will receive either placebo, 25 mg INT-747, or 50 mg INT-747 by mouth daily for 6 weeks.
The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43). Other endpoints will be evaluated by monitoring adverse experiences; vital signs; clinical laboratory values; plasma drug and metabolite concentrations; and general health and well-being.
- Conditions
- Diabetes Mellitus, Type II, Fatty Liver
- Being tested
- INT-747, Placebo
- Keywords
- Farnesoid X receptor agonist, Metabolic Disorder, Diabetes, NAFLD
- Medical subject headings
- Diabetes Mellitus, Type 2, Fatty Liver, Metabolic Diseases, Diabetes Mellitus, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INT-747Drug
25 mg by mouth once daily, 50 mg by mouth once daily
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 25 mg INT-747 | Active comparator | Not described Receives: Drug: INT-747 |
| 50 mg INT-747 | Active comparator | Not described Receives: Drug: INT-747 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Resistance and Glucose Homeostasis
The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43).
Measured: baseline and 6 weeks
Secondary outcomes (1)
Hepatocellular Function
Hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionFeb 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type IIStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intercept Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David A Shapiro, M.D., Study director, Intercept Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501592
- Sponsor's protocol ID
- 747-203
- Status last verified
- Apr 2012
- First submitted
- 13 Jul 2007
- Last updated
- 20 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mudaliar S, Henry RR, Sanyal AJ, Morrow L, Marschall HU, Kipnes M, Adorini L, Sciacca CI, Clopton P, Castelloe E, Dillon P, Pruzanski M, Shapiro D. Efficacy and safety of the farnesoid X receptor agonist obeticholic acid in patients with type 2 diabetes and nonalcoholic fatty liver disease. Gastroenterology. 2013 Sep;145(3):574-82.e1. doi: 10.1053/j.gastro.2013.05.042. Epub 2013 May 30.
PubMed 23727264
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of INT-747 in Patients With Type 2 Diabetes Mellitus and Presumed Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT00501592
- Acronym / sponsor ID
- 747-203
- Conditions
- Diabetes Mellitus, Type II, Fatty Liver
- Keywords
- Farnesoid X receptor agonist, Metabolic Disorder, Diabetes, NAFLD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Intercept PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Posted 27 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following:
- The safety and tolerability of multiple doses of INT 747;
- The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and glucose homeostasis;
- Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function and inflammation, and;
- Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic acid (6-EDCA) and tauro 6-ECDCA.
Detailed description
This is a multi-center, double-blind, randomized, placebo-controlled, multiple-dose, parallel-group study. Three (3) cohorts of 12 patients each will receive either placebo, 25 mg INT-747, or 50 mg INT-747 by mouth daily for 6 weeks.
The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43). Other endpoints will be evaluated by monitoring adverse experiences; vital signs; clinical laboratory values; plasma drug and metabolite concentrations; and general health and well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 25 mg INT-747 | Active comparator | Drug: INT-747 |
| 50 mg INT-747 | Active comparator | Drug: INT-747 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Type 2 diabetes, defined by the American Diabetes Association (ADA), as one of the following criteria:
- Symptoms of diabetes plus casual plasma glucose concentration >200 mg/dL (11.1 mmol/L) or
- Fasting plasma glucose >126 mg/dL (7.0 mmol/L) or
- 2-hour post-load glucose >200 mg/dL (11.1 mmol/L) during a 75 g oral glucose tolerance test (GTT).
- Presumed NAFLD, defined by one of the following criteria:
Key exclusion criteria (4 listed)
- Bilirubin >2 × ULN
- ALT >155 U/L for females and >185 U/L for males.
- AST >155 U/L for females and >200 U/L for males.
- Patients taking any antidiabetic medications, with the exception of metformin and sulfonylureas. If the HbA1c is <11%, patients may be enrolled who have been withdrawn from all other diabetic medications as specified in the protocol, at the discretion of the Principal Investigator.
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 |
|---|---|---|
| INT-74725 mg by mouth once daily, 50 mg by mouth once daily | Drug | 25 mg INT-747, 50 mg INT-747 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Insulin Resistance and Glucose Homeostasis
Time frame: baseline and 6 weeks
The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43).
1 secondary outcome
Hepatocellular Function
Time frame: baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23727264Mudaliar S, Henry RR, Sanyal AJ, Morrow L, Marschall HU, Kipnes M, Adorini L, Sciacca CI, Clopton P, Castelloe E, Dillon P, Pruzanski M, Shapiro D. Efficacy and safety of the farnesoid X receptor agonist obeticholic acid in patients with type 2 diabetes and nonalcoholic fatty liver disease. Gastroenterology. 2013 Sep;145(3):574-82.e1. doi: 10.1053/j.gastro.2013.05.042. Epub 2013 May 30.
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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.
David A Shapiro, M.D. study director
Intercept Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INT-747 in people with Diabetes Mellitus, Type II and Fatty Liver, run by Intercept Pharmaceuticals at 4 sites 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 9 inclusion and 4 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 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Insulin Resistance and Glucose Homeostasis (time frame: baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00501592, which also lists 1 linked publication.
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 20 Apr 2012.