Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients

NCT01490918 | Completed Phase 4 Results DMC

• 1 other identifier: ACADEMIC
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective To evaluate the efficacy of Acarbose add-on therapy on glucose control in subjects with type 2 diabetes inadequately controlled with Metformin and Sitagliptin combination therapy. The effect of acarbose, an alpha glucosidase inhibitor as a third-line therapeutic medication in subject who are inadequately controlled with metformin and DPP4 inhibitor will be evaluated with multicenter, randomized, 24-week, double blinded, placebo-controlled study in Korea.

Conditions

Type 2 Diabetes Mellitus

Keywords

Acarbose; ACADEMIC

Outcome Measures

Primary Outcomes (1)

• The Change of Glycated Hemoglogin(HbA1c) From Baseline to 16 Weeks of Treatment

  The change of glycated hemoglogin(HbA1c) from baseline to 16 weeks of treatment between Placebo + Metformin+Sitagliptin and Metformin + Sitagliptin + Acarbose group

  baseline, 16 weeks

Secondary Outcomes (7)

• The Change of HbA1c From Baseline to 24 Weeks of Treatment

  baseline, 24 weeks

• The Change of PPG2hr From Baseline to 24 Weeks of Treatment

  baseline, 24 weeks

• Changes in Glucose During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),

  Visit 2(baseline) and Visit 5(16W)

• Changes in Insulin During Mixed Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),

  Visit 2(baseline) and Visit 5(16W)

• Change in Active GLP-1 at 0 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2)

  baseline, 16 week

Other Outcomes (3)

• Changes in Mean Glucose During CGMS Between 3 Group

  Visit 2(baseline) and Visit 5(16W)

• Changes in Variation of Glucose During CGMS Between 3 Group

  Visit 2(baseline) and Visit 5(16W)

• Changes in MAGE of Glucose During CGMS Between 2 Group(Group 1 vs Group 2),

  Visit 2(baseline) and Visit 5(16W)

Study Arms (3)

Acarbose placebo, Metformin, Sitagliptin

PLACEBO COMPARATOR

The Acarbose placebo should be changed into real Acarbose from the 16th week.

Drug: Placebo acarbose

Sitagliptin, Metformin, Acarbose

EXPERIMENTAL

Metformin, Sitagliptin, Acarbose group

Drug: Acarbose

Metformin placebo, Sitagliptin, Acarbose

OTHER

The Metformin placebo should be changed into real Metformin from the 16th week.

Drug: placebo metformin

Interventions

Acarbose DRUG

Acarbose 50mg b.i.d at first, at the 2nd week 50mg t.i.d and the 4th week, 100mg tid.

Also known as: triple combination

Sitagliptin, Metformin, Acarbose

Placebo acarbose DRUG

acarbose placebo

Also known as: dual combination (metformin+sitagliptin)

Acarbose placebo, Metformin, Sitagliptin

placebo metformin DRUG

metformin placebo

Also known as: dual combination (acarbose + sitagliptin)

Metformin placebo, Sitagliptin, Acarbose

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with type-II diabetes mellitus;
• Subjects aged between 20 and 80;
• Subjects whose HbA1c ratio is between 7.0% and 10.0%;
• Subjects who took Metformin and Sitagliptin for at least 12 weeks;
• Subjects who were given the explanation about this clinical study and signed the consent form.

You may not qualify if:

• Subjects who have taken drugs that are likely to affect blood glucose or who need to take such drugs, e.g., glucocorticoid;
• Subjects with severe renal diseases (men: Scr\>1.5 / women: Scr\>1.4);
• Subjects with severe liver diseases or whose AST and ALT are at least 2.5 times higher than the upper limits of normal (ULN);
• Subjects having the case history of lactic acidosis;
• Subjects who have the case history of myocardial infarction or unstable angina or who underwent the coronary artery bypass graft 6 months before the screening test or who have arrhythmia to be treated;
• Subjects with congestive heart failures to be treated;
• Subjects who fall into New York Heart Association (NYHA) class III or IV;
• Subjects having the case history of acute or chronic metabolic acidosis including ketoacidosis;
• Subjects who have been pregnant or who are in the period of lactation;
• Subjects diagnosed with malignant tumors within 5 years;
• Subjects who are hypersensitive to Metformin, Sitagliptin and Acarbose or their ingredients;
• Subjects with inflammatory bowel diseases or intestinal ulcers or enterostenosis (includes Subjects who are vulnerable to enterostenosis) or chronic enteric diseases related to digestion and absorption or whose symptoms are likely to worsen due to intestinal gas;
• Subjects who participated in other clinical studies as Subjects within 60 days before this study (or before taking the investigational drugs);
• Subjects judged unfit for this study by investigators.

Sponsors & Collaborators

• The Catholic University of Korea: lead
• Bayer: collaborator

Study Sites (1)

MedicalExcellence

Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Acarbose; Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Metformin; Biguanides; Guanidines; Amidines; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

Evaluation of GIP and oxidative stress markers (8-OHdG, Nitrotyrosin) were not analyzed due to limited number of sample and technical problems leading to uninterpretable data.

Results Point of Contact

• Title: Yoon Hee Choi
• Organization: The Catholic University of Korea, Seoul St Mary's Hospital

choiyh@catholic.ac.kr

82-2-2258-8288

Study Officials

• Kun-HO Yoon, professor

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: placebo medication
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medical doctor

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 13, 2011
• Study Start: April 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 17, 2020
• Results First Posted: August 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)