Type II DiabetesPhase 4NCT02365233
Fatty Liver Study in Patients With Type II Diabetes
A Phase 4 study testing DPP4 inhibitor, Pioglitazone and Lantus insulin in people with Type II Diabetes and Nonalcoholic Fatty Liver, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The primary objective of this trial is to measure changes in hepatic lipid content using three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes, Nonalcoholic Fatty Liver
- What is being tested?
- DPP4 inhibitor, Pioglitazone and Lantus insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2013to 31 Dec 2016
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent in a manner approved by the Institutional Review Board (IRB) and is willing and able to comply with the trial procedures.
- Adults at least 18 years of age at the time of consent.
- Have type 2 diabetes mellitus.
- Be on a stable medication with metformin (2000 mg/day) for at least 3 months prior to study enrollment.
- Have blood A1c >7.6% and < 8.5% within 3 months prior to study enrollment.
- Have fatty liver, which is diagnosed by ultrasonographic findings of "bright liver" within 1 year of study enrollment.
- Stable medication for lipid lowering, blood pressure control, dietary supplements, including vitamins, for at least 3 months.
- Women of Childbearing Potential must be willing and able to use acceptable forms of birth control while on the study.
Who cannot join
- Currently taking medication that can affect glucose metabolism other than Metformin.
- History of Kidney diseases that, in the opinion of the investigator , would place the subject at increased risk of participation or plasma levels of creatinine > 1.4 for women and > 1.5 for men.
- History of Cirrhosis of liver, hepatitis, or other liver diseases that, in the opinion of the investigator, would place the subject at increased risk of participation.
- Current alcohol consumption more than12 to 15 g of alcohol a day, or >12 oz of beer, 5 oz of wine, or 1.5 oz of distilled spirits.
- History of heart failure.
- Concurrent participation on another research study
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- Use of an investigational agent in the 30 days prior to signing informed consent.
- History of prior non-compliance or the presence or history of psychiatric conditions (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
- Females who are pregnant or lactating
- Current Diagnosis or History of Bladder Cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch -Galveston
Galveston, Texas, 77555
About this study
Official title: A Phase IV, Open Label, Randomized Trial on the Effect of Metformin Plus Lantus Insulin, Pioglitazone, or DPP4 Inhibitor on Fatty Liver in Patients With Type II Diabetes
The primary objective of this trial is to measure changes in hepatic lipid content using three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
Read the detailed description
In patients with type 2 diabetes whose glycemic control is not accomplished with Metformin alone, there are several options for additional hypoglycemic agent. As per recent National guidelines at least three "second line" agents can be added to metformin: thiazolidinediones, Lantus insulin, and DPP4 inhibitors. All three approaches have been proven to help accomplishing goals of therapy for glycemic control (HbA1c<7%) in clinical trials. Whether one approach is superior to the other in improving associated non-glycemic metabolic abnormalities and risk for future morbidity and mortality in patients with type 2 diabetes remains a matter of intense debate. Among these abnormalities, excessive triglyceride content in the liver (fatty liver or liver steatosis) is a major predictor of risk for non-alcoholic steato-hepatitis (NASH) and liver cirrhosis. Fatty liver is highly prevalent in patients with type 2 diabetes. There are no clinical studies done to determine if any of these three therapeutic options is superior at reducing the liver triglyceride content in patients with type 2 diabetes and fatty Liver. Therefore, in this study we propose to measure and compare the effects on liver triglyceride content when either pioglitazone, lantus insulin, or DPP4 inhibitors are added to metformin in patients with poorly controlled type 2 diabetes (HbA1c>7.6%) and fatty liver (presence of "bright" liver in abdominal ultrasound). The primary objective of this trial is to measure changes in hepatic lipid content using three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
- Conditions
- Type II Diabetes, Nonalcoholic Fatty Liver
- Being tested
- DPP4 inhibitor, Pioglitazone, Lantus insulin
- Keywords
- Type II Diabetes, Nonalcoholic fatty liver
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPP4 inhibitorDrug
Also called sitagliptin100 mg daily, saxagliptin 5 mg daily
Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
PioglitazoneDrug
Also called Pioglitazone 15 mg daily
Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
Lantus insulinDrug
Also called Lantus insulin (0.35U/kg of body weight once daily)
Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
| Study group | Role | What they receive |
|---|---|---|
| Thiazolidinedione | Active comparator | (Pioglitazone, 15 mg/day) Receives: Drug: Pioglitazone |
| Lantus Insulin | Active comparator | 0.35 U per kg body weight once daily Receives: Drug: Lantus insulin |
| DPP4 inhibitor | Active comparator | Sitagliptin, 100 mg/day or Saxagliptin, 5 mg/day Receives: Drug: DPP4 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hepatic Lipid Content From Baseline Visit to Six Month Follow up Visit
Comparison of the hepatic lipid content measurement taken by MRI at baseline with the measurement taken by MRI at the 6 month follow up visit.
Measured: Hepatic lipid content measurement will be taken on Day #1 ( the day of randomization) and at the 6 month follow up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study start1 May 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Why it stopped: IRB withheld the data due to inadequate supporting documentation
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.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicola Abate, MD, Principal investigator, University of Texas Medical Branch-Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365233
- Sponsor's protocol ID
- 13-021
- Status last verified
- Apr 2018
- First submitted
- 9 May 2013
- Last updated
- 31 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open Label, Randomized Trial on the Effect of Metformin Plus Lantus Insulin, Pioglitazone, or DPP4 Inhibitor on Fatty Liver in Patients With Type II Diabetes
- ClinicalTrials.gov ID
- NCT02365233
- Acronym / sponsor ID
- 13-021
- Conditions
- Type II Diabetes, Nonalcoholic Fatty Liver
- Keywords
- Type II Diabetes, Nonalcoholic fatty liver
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB withheld the data due to inadequate supporting documentation
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Posted 31 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to measure changes in hepatic lipid content using three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
Detailed description
In patients with type 2 diabetes whose glycemic control is not accomplished with Metformin alone, there are several options for additional hypoglycemic agent. As per recent National guidelines at least three "second line" agents can be added to metformin: thiazolidinediones, Lantus insulin, and DPP4 inhibitors. All three approaches have been proven to help accomplishing goals of therapy for glycemic control (HbA1c<7%) in clinical trials. Whether one approach is superior to the other in improving associated non-glycemic metabolic abnormalities and risk for future morbidity and mortality in patients with type 2 diabetes remains a matter of intense debate. Among these abnormalities, excessive triglyceride content in the liver (fatty liver or liver steatosis) is a major predictor of risk for non-alcoholic steato-hepatitis (NASH) and liver cirrhosis. Fatty liver is highly prevalent in patients with type 2 diabetes. There are no clinical studies done to determine if any of these three therapeutic options is superior at reducing the liver triglyceride content in patients with type 2 diabetes and fatty Liver. Therefore, in this study we propose to measure and compare the effects on liver triglyceride content when either pioglitazone, lantus insulin, or DPP4 inhibitors are added to metformin in patients with poorly controlled type 2 diabetes (HbA1c>7.6%) and fatty liver (presence of "bright" liver in abdominal ultrasound). The primary objective of this trial is to measure changes in hepatic lipid content using three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thiazolidinedione | Active comparator | Drug: Pioglitazone(Pioglitazone, 15 mg/day) |
| Lantus Insulin | Active comparator | Drug: Lantus insulin0.35 U per kg body weight once daily |
| DPP4 inhibitor | Active comparator | Drug: DPP4 inhibitorSitagliptin, 100 mg/day or Saxagliptin, 5 mg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject has provided informed consent in a manner approved by the Institutional Review Board (IRB) and is willing and able to comply with the trial procedures.
- Adults at least 18 years of age at the time of consent.
- Have type 2 diabetes mellitus.
- Be on a stable medication with metformin (2000 mg/day) for at least 3 months prior to study enrollment.
- Have blood A1c >7.6% and < 8.5% within 3 months prior to study enrollment.
Key exclusion criteria (10 listed)
- Currently taking medication that can affect glucose metabolism other than Metformin.
- History of Kidney diseases that, in the opinion of the investigator , would place the subject at increased risk of participation or plasma levels of creatinine > 1.4 for women and > 1.5 for men.
- History of Cirrhosis of liver, hepatitis, or other liver diseases that, in the opinion of the investigator, would place the subject at increased risk of participation.
- Current alcohol consumption more than12 to 15 g of alcohol a day, or >12 oz of beer, 5 oz of wine, or 1.5 oz of distilled spirits.
- History of heart failure.
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 |
|---|---|---|
| DPP4 inhibitorAlso: sitagliptin100 mg daily, saxagliptin 5 mg dailyComparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone. | Drug | DPP4 inhibitor |
| PioglitazoneAlso: Pioglitazone 15 mg dailyComparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone. | Drug | Thiazolidinedione |
| Lantus insulinAlso: Lantus insulin (0.35U/kg of body weight once daily)Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone. | Drug | Lantus Insulin |
Primary outcome
Change in Hepatic Lipid Content From Baseline Visit to Six Month Follow up Visit
Time frame: Hepatic lipid content measurement will be taken on Day #1 ( the day of randomization) and at the 6 month follow up visit.
Comparison of the hepatic lipid content measurement taken by MRI at baseline with the measurement taken by MRI at the 6 month follow up visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nicola Abate, MD principal investigator
University of Texas Medical Branch-Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DPP4 inhibitor, Pioglitazone and Lantus insulin in people with Type II Diabetes and Nonalcoholic Fatty Liver, run by The University of Texas Medical Branch, Galveston 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 10 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: stopped early, as of the sponsor's last update on 31 Jul 2018. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 31 Jul 2018). 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?
Change in Hepatic Lipid Content From Baseline Visit to Six Month Follow up Visit (time frame: Hepatic lipid content measurement will be taken on Day #1 ( the day of randomization) and at the 6 month follow up visit.). 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 31 Jul 2018.