Type 2 Diabetes MellitusPhase 4NCT01337440

Efficacy and Safety of Ursodeoxycholic Acid (UDCA) Added to the DPP-4 Inhibitor in People With Type 2 Diabetes and Chronic Liver Diseases

A Phase 4 study testing UDCA and Sitagliptin in people with Type 2 Diabetes Mellitus and Chronic Liver Disease, run by Kanazawa University at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

1. Objectives 1. To test whether Ursodeoxycholic Acid (UDCA) increases Glucagon-like peptide-1 (GLP-1) response to nutrients and improves glycemic control in people with type 2 diabetes. 2. To test whether sitagliptin enhances UDCA-induced beneficial effect in GLP-1 levels and glycemic control. 3. Read more about this study

Who is it for?: Any age
Conditions the study is for: Type 2 Diabetes Mellitus, Chronic Liver Disease
What is being tested?: UDCA and Sitagliptin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteJapan
Study dates: Apr 2010to Mar 2013
Phase: Phase 4
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Type 2 diabetes
HbA1c >=6.5% during 8 weeks prior to the study
Treated with none or single oral hypoglycemic agent(OHA: sulfonyl ureas, biguanides, or thiazolidinediones) over 12 weeks prior to the study

Who cannot join

Non-Type 2 diabetes
Medical history and/or complication of diabetic ketoacidosis
Medical history and/or complication of severe hypoglycemia
Insulin treatment within 16 weeks prior to the study
Treatment with alpha-glucosidase inhibitors or sitagliptin within 12 weeks prior to the study
Treatment with glucocorticoid

Show all 13Show fewer

Unstable glycemic control
Hypersensitivity to or contraindication of sitagliptin and voglibose
Aspartate transaminase (AST) or alanine transaminase (ALT) >=2.5 time of institutional upper normal limit
Uncontrolled hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
Severe health problems not suitable for the study
Pregnant or lactating women
Hepatitis B or C

Trial locations and contacts

1 site in 1 country.

Toshinari Takamura, MD, PhD contact

+81-76-265-2233

ttakamura@m-kanazawa.jp

Japan1 site, 1 recruiting

Internal medicine, Kanazawa university hospital
Kanazawa, Ishikawa-ken, 920-8641
Toshinari Takamura, MD, PhD, +81-76-265-2233, ttakamura@m-kanazawa.jp
Kosuke R Shima, MD
Recruiting

Other trials in Japan

About this study

Official title: The Efficacy and Safety of Ursodeoxycholic Acid (UDCA) Added to the Dipeptidyl Peptidase-4 Inhibitor, Sitagliptin in People With Type 2 Diabetes and Chronic Liver Diseases

Objectives
To test whether Ursodeoxycholic Acid (UDCA) increases Glucagon-like peptide-1 (GLP-1) response to nutrients and improves glycemic control in people with type 2 diabetes.
To test whether sitagliptin enhances UDCA-induced beneficial effect in GLP-1 levels and glycemic control.
To test safety of combination therapy of sitagliptin and UDCA in people with type 2 diabetes.
Clinical hypothesis.
UDCA increases GLP-1 response to nutrients via provoking bile acids excretion from the liver to the intestine/colon.
UDCA improves glycemic control in people with type 2 diabetes.
Sitagliptin enhances UDCA-induced response of GLP-1 to nutrients.
Sitagliptin has additive beneficial effects with UDCA in glycemic control in people with type 2 diabetes.
Combination therapy of sitagliptin and UDCA is safe and well-tolerated in people with type 2 diabetes.
The combination therapy may loose weight by unique mechanisms of each agent; GLP-1 inhibits appetite by acting on CNS and gastrointestinal motility, whereas UDCA-enhanced circulating primary bile acids increases energy expenditure through the pathway involving G protein-coupled bile acid receptor 1 (Gpbar1, or M-Bar, TGR-5) and subsequent activation of type 2 iodothyronine deiodinase (D2) in brown adipose and muscle tissues, as reported previously.

Conditions: Type 2 Diabetes Mellitus, Chronic Liver Disease
Being tested: UDCA, Sitagliptin
Keywords: Ursodeoxycholic Acid, sitagliptin, bile acids, GLP-1
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.

UDCADrug
Also called Ursodeoxycholic acid (UDCA) goes by the trade names Urso.
Sitagliptin: 50 mg, po, qd for 12 weeks, then UDCA add-on therapy for additional 12 weeks.
UDCA dosage: dosing from 600 mg for initial 4 weeks. Then, if there is no adverse effect, UDCA is escalated to 900 mg, po, tid.
SitagliptinDrug
Also called Sitagliptin sold under the trade name Januvia
UDCA for 12 weeks, then Sitagliptin add-on therapy for additional 12 weeks.
UDCA dosage: dosing from 600 mg for initial 4 weeks. Then, if there is no adverse effect, UDCA is escalated to 900 mg, po, tid.

Study groups in NCT01337440
Study group	Role	What they receive
UDCA pretreatment	Active comparator	Ursodeoxycholic Acid (UDCA) for 12 weeks, then Sitagliptin add-on therapy for additional 12 weeks. UDCA dosage: dosing from 600 mg for initial 4 weeks. Then, if there is no adverse effect, UDCA is escalated to 900 mg, po, tid. Receives: Drug: Sitagliptin
Sitagliptin pretreatment	Active comparator	Sitagliptin: 50 mg, po, qd for 12 weeks, then UDCA add-on therapy for additional 12 weeks. UDCA dosage: dosing from 600 mg for initial 4 weeks. Then, if there is no adverse effect, UDCA is escalated to 900 mg, po, tid. Receives: Drug: UDCA

What is being measured

The primary outcome is the main question the study is designed to answer.

the difference of haemoglobin A1c (HbA1c) and glycoalbumin (GA)
the difference of haemoglobin A1c (HbA1c) and glycoalbumin (GA) treating by Ursodeoxycholic Acid (UDCA)or sitagliptin monotherapy, and combination therapy of both two drugs for 3 monthes.
Measured: 6 months

Secondary outcomes (4)

Change from Baseline in Glucagon-like peptide-1 (GLP-1) response to lipid meal test (fat 55%)
Measured: 6 months
Change from Baseline in energy expenditure
Measured: 6months
Change from Baseline in fasting plasma glucose level
Measured: 6months
change from baseline in autonomic nerve function
This is performed by power-spectrum analyses of heart rate variability
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Mar 2013

First posted18 Apr 2011 (estimated)
Study startApr 2010
Primary completionMar 2013 (estimated)
Study completionMar 2013 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01337440
Sponsor's protocol ID: KanazawaU-1
Status last verified: Apr 2011
First submitted: 16 Sep 2010
Last updated: 18 Apr 2011
Results posted: No
Data monitoring committee: Yes

Publications

Sakurai M, Takamura T, Ota T, Ando H, Akahori H, Kaji K, Sasaki M, Nakanuma Y, Miura K, Kaneko S. Liver steatosis, but not fibrosis, is associated with insulin resistance in nonalcoholic fatty liver disease. J Gastroenterol. 2007 Apr;42(4):312-7. doi: 10.1007/s00535-006-1948-. Epub 2007 Apr 26.
PubMed 17464461
Takamura T, Sakurai M, Nakamura M, Shimizu A, Ota T, Misu H, Takeshita Y, Tsuchiyama N, Kurita S, Ando H, Kaneko S. Factors associated with improvement of fasting plasma glucose level by mealtime dosing of a rapid-acting insulin analog in type 2 diabetes. Diabetes Res Clin Pract. 2007 Mar;75(3):278-84. doi: 10.1016/j.diabres.2006.07.019. Epub 2006 Oct 27.
PubMed 17069922
Tsuchiyama N, Takamura T, Ando H, Sakurai M, Shimizu A, Kato K, Kurita S, Kaneko S. Possible role of alpha-cell insulin resistance in exaggerated glucagon responses to arginine in type 2 diabetes. Diabetes Care. 2007 Oct;30(10):2583-7. doi: 10.2337/dc07-0066. Epub 2007 Jul 20.
PubMed 17644622
Hamaguchi E, Takamura T, Sakurai M, Mizukoshi E, Zen Y, Takeshita Y, Kurita S, Arai K, Yamashita T, Sasaki M, Nakanuma Y, Kaneko S. Histological course of nonalcoholic fatty liver disease in Japanese patients: tight glycemic control, rather than weight reduction, ameliorates liver fibrosis. Diabetes Care. 2010 Feb;33(2):284-6. doi: 10.2337/dc09-0148. Epub 2009 Oct 30.
PubMed 19880582
Watanabe M, Houten SM, Mataki C, Christoffolete MA, Kim BW, Sato H, Messaddeq N, Harney JW, Ezaki O, Kodama T, Schoonjans K, Bianco AC, Auwerx J. Bile acids induce energy expenditure by promoting intracellular thyroid hormone activation. Nature. 2006 Jan 26;439(7075):484-9. doi: 10.1038/nature04330. Epub 2006 Jan 8.
PubMed 16400329
Amori RE, Lau J, Pittas AG. Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA. 2007 Jul 11;298(2):194-206. doi: 10.1001/jama.298.2.194.
PubMed 17622601
Thomas C, Gioiello A, Noriega L, Strehle A, Oury J, Rizzo G, Macchiarulo A, Yamamoto H, Mataki C, Pruzanski M, Pellicciari R, Auwerx J, Schoonjans K. TGR5-mediated bile acid sensing controls glucose homeostasis. Cell Metab. 2009 Sep;10(3):167-77. doi: 10.1016/j.cmet.2009.08.001.
PubMed 19723493
Lazaridis KN, Gores GJ, Lindor KD. Ursodeoxycholic acid 'mechanisms of action and clinical use in hepatobiliary disorders'. J Hepatol. 2001 Jul;35(1):134-46. doi: 10.1016/s0168-8278(01)00092-7.
PubMed 11495032
Shima KR, Ota T, Kato KI, Takeshita Y, Misu H, Kaneko S, Takamura T. Ursodeoxycholic acid potentiates dipeptidyl peptidase-4 inhibitor sitagliptin by enhancing glucagon-like peptide-1 secretion in patients with type 2 diabetes and chronic liver disease: a pilot randomized controlled and add-on study. BMJ Open Diabetes Res Care. 2018 Mar 17;6(1):e000469. doi: 10.1136/bmjdrc-2017-000469. eCollection 2018.
PubMed 29607050

Want to know more?

Toshinari Takamura, MD, PhD

+81-76-265-2233

ttakamura@m-kanazawa.jp

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Safety of Ursodeoxycholic Acid (UDCA) Added to the Dipeptidyl Peptidase-4 Inhibitor, Sitagliptin in People With Type 2 Diabetes and Chronic Liver Diseases
ClinicalTrials.gov ID: NCT01337440
Acronym / sponsor ID: KanazawaU-1
Conditions: Type 2 Diabetes Mellitus, Chronic Liver Disease
Keywords: Ursodeoxycholic Acid, sitagliptin, bile acids, GLP-1
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 20 participants (estimated)
Lead sponsor: Kanazawa UniversityUniversity, hospital or other
Study start: Apr 2010
Primary completion: Mar 2013 (estimated)
Study completion: Mar 2013 (estimated)
First posted: 18 Apr 2011 (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.

Objectives
To test whether Ursodeoxycholic Acid (UDCA) increases Glucagon-like peptide-1 (GLP-1) response to nutrients and improves glycemic control in people with type 2 diabetes.
To test whether sitagliptin enhances UDCA-induced beneficial effect in GLP-1 levels and glycemic control.
To test safety of combination therapy of sitagliptin and UDCA in people with type 2 diabetes.
Clinical hypothesis.
UDCA increases GLP-1 response to nutrients via provoking bile acids excretion from the liver to the intestine/colon.
UDCA improves glycemic control in people with type 2 diabetes.
Sitagliptin enhances UDCA-induced response of GLP-1 to nutrients.
Sitagliptin has additive beneficial effects with UDCA in glycemic control in people with type 2 diabetes.
Combination therapy of sitagliptin and UDCA is safe and well-tolerated in people with type 2 diabetes.
The combination therapy may loose weight by unique mechanisms of each agent; GLP-1 inhibits appetite by acting on CNS and gastrointestinal motility, whereas UDCA-enhanced circulating primary bile acids increases energy expenditure through the pathway involving G protein-coupled bile acid receptor 1 (Gpbar1, or M-Bar, TGR-5) and subsequent activation of type 2 iodothyronine deiodinase (D2) in brown adipose and muscle tissues, as reported previously.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
UDCA pretreatment	Active comparator	Drug: SitagliptinUrsodeoxycholic Acid (UDCA) for 12 weeks, then Sitagliptin add-on therapy for additional 12 weeks. UDCA dosage: dosing from 600 mg for initial 4 weeks. Then, if there is no adverse effect, UDCA is escalated to 900 mg, po, tid.
Sitagliptin pretreatment	Active comparator	Drug: UDCASitagliptin: 50 mg, po, qd for 12 weeks, then UDCA add-on therapy for additional 12 weeks. UDCA dosage: dosing from 600 mg for initial 4 weeks. Then, if there is no adverse effect, UDCA is escalated to 900 mg, po, tid.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Type 2 diabetes
HbA1c >=6.5% during 8 weeks prior to the study
Treated with none or single oral hypoglycemic agent(OHA: sulfonyl ureas, biguanides, or thiazolidinediones) over 12 weeks prior to the study

Key exclusion criteria (13 listed)

Non-Type 2 diabetes
Medical history and/or complication of diabetic ketoacidosis
Medical history and/or complication of severe hypoglycemia
Insulin treatment within 16 weeks prior to the study
Treatment with alpha-glucosidase inhibitors or sitagliptin within 12 weeks prior to the study

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
UDCAAlso: Ursodeoxycholic acid (UDCA) goes by the trade names Urso.Sitagliptin: 50 mg, po, qd for 12 weeks, then UDCA add-on therapy for additional 12 weeks. UDCA dosage: dosing from 600 mg for initial 4 weeks. Then, if there is no adverse effect, UDCA is escalated to 900 mg, po, tid.	Drug	Sitagliptin pretreatment
SitagliptinAlso: Sitagliptin sold under the trade name JanuviaUDCA for 12 weeks, then Sitagliptin add-on therapy for additional 12 weeks. UDCA dosage: dosing from 600 mg for initial 4 weeks. Then, if there is no adverse effect, UDCA is escalated to 900 mg, po, tid.	Drug	UDCA pretreatment

Primary outcome

the difference of haemoglobin A1c (HbA1c) and glycoalbumin (GA)
Time frame: 6 months
the difference of haemoglobin A1c (HbA1c) and glycoalbumin (GA) treating by Ursodeoxycholic Acid (UDCA)or sitagliptin monotherapy, and combination therapy of both two drugs for 3 monthes.

4 secondary outcomes

Change from Baseline in Glucagon-like peptide-1 (GLP-1) response to lipid meal test (fat 55%)
Time frame: 6 months
Change from Baseline in energy expenditure
Time frame: 6months
Change from Baseline in fasting plasma glucose level
Time frame: 6months
change from baseline in autonomic nerve function
Time frame: 6 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2011.
Background: PubMed 17464461Sakurai M, Takamura T, Ota T, Ando H, Akahori H, Kaji K, Sasaki M, Nakanuma Y, Miura K, Kaneko S. Liver steatosis, but not fibrosis, is associated with insulin resistance in nonalcoholic fatty liver disease. J Gastroenterol. 2007 Apr;42(4):312-7. doi: 10.1007/s00535-006-1948-. Epub 2007 Apr 26.
Background: PubMed 17069922Takamura T, Sakurai M, Nakamura M, Shimizu A, Ota T, Misu H, Takeshita Y, Tsuchiyama N, Kurita S, Ando H, Kaneko S. Factors associated with improvement of fasting plasma glucose level by mealtime dosing of a rapid-acting insulin analog in type 2 diabetes. Diabetes Res Clin Pract. 2007 Mar;75(3):278-84. doi: 10.1016/j.diabres.2006.07.019. Epub 2006 Oct 27.
Background: PubMed 17644622Tsuchiyama N, Takamura T, Ando H, Sakurai M, Shimizu A, Kato K, Kurita S, Kaneko S. Possible role of alpha-cell insulin resistance in exaggerated glucagon responses to arginine in type 2 diabetes. Diabetes Care. 2007 Oct;30(10):2583-7. doi: 10.2337/dc07-0066. Epub 2007 Jul 20.
Results publication: PubMed 19880582Hamaguchi E, Takamura T, Sakurai M, Mizukoshi E, Zen Y, Takeshita Y, Kurita S, Arai K, Yamashita T, Sasaki M, Nakanuma Y, Kaneko S. Histological course of nonalcoholic fatty liver disease in Japanese patients: tight glycemic control, rather than weight reduction, ameliorates liver fibrosis. Diabetes Care. 2010 Feb;33(2):284-6. doi: 10.2337/dc09-0148. Epub 2009 Oct 30.
Results publication: PubMed 16400329Watanabe M, Houten SM, Mataki C, Christoffolete MA, Kim BW, Sato H, Messaddeq N, Harney JW, Ezaki O, Kodama T, Schoonjans K, Bianco AC, Auwerx J. Bile acids induce energy expenditure by promoting intracellular thyroid hormone activation. Nature. 2006 Jan 26;439(7075):484-9. doi: 10.1038/nature04330. Epub 2006 Jan 8.
Results publication: PubMed 17622601Amori RE, Lau J, Pittas AG. Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA. 2007 Jul 11;298(2):194-206. doi: 10.1001/jama.298.2.194.
Results publication: PubMed 19723493Thomas C, Gioiello A, Noriega L, Strehle A, Oury J, Rizzo G, Macchiarulo A, Yamamoto H, Mataki C, Pruzanski M, Pellicciari R, Auwerx J, Schoonjans K. TGR5-mediated bile acid sensing controls glucose homeostasis. Cell Metab. 2009 Sep;10(3):167-77. doi: 10.1016/j.cmet.2009.08.001.
Results publication: PubMed 11495032Lazaridis KN, Gores GJ, Lindor KD. Ursodeoxycholic acid 'mechanisms of action and clinical use in hepatobiliary disorders'. J Hepatol. 2001 Jul;35(1):134-46. doi: 10.1016/s0168-8278(01)00092-7.
Derived from this study: PubMed 29607050Shima KR, Ota T, Kato KI, Takeshita Y, Misu H, Kaneko S, Takamura T. Ursodeoxycholic acid potentiates dipeptidyl peptidase-4 inhibitor sitagliptin by enhancing glucagon-like peptide-1 secretion in patients with type 2 diabetes and chronic liver disease: a pilot randomized controlled and add-on study. BMJ Open Diabetes Res Care. 2018 Mar 17;6(1):e000469. doi: 10.1136/bmjdrc-2017-000469. eCollection 2018.

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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.

Toshinari Takamura, MD, PhD contact

+81-76-265-2233

ttakamura@m-kanazawa.jp

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 UDCA and Sitagliptin in people with Type 2 Diabetes Mellitus and Chronic Liver Disease, run by Kanazawa University at 1 site in Japan.

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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 18 Apr 2011. 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 Japan. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Toshinari Takamura, MD, PhD (+81-76-265-2233, ttakamura@m-kanazawa.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the difference of haemoglobin A1c (HbA1c) and glycoalbumin (GA) (time frame: 6 months). 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 NCT01337440, which also lists 9 linked publications.

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 18 Apr 2011.