Glimepiride, Alogliptin and Alogliptin+Pioglitazone Combination

NCT04470310 | Unknown Phase 4

• 1 other identifier: Takeda_ALO-IIT
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

• This trial is a three-armed, open label, random assignment trial.
• The research subjects are patients who are first starting their treatment or patients who have failed with the metformin treatment and are changing their medication. They will be assigned to one of the following treatment groups: the glimepiride monotherapy treatment group, the alogliptin monotherapy treatment group, and the alogliptin - pioglitazone combination therapy treatment group
• This trial is a prospective trial which will conduct surveys 6 times over the course of the 6 months in which each treatment group is administered drugs (Week -2, Baseline, Week 4, Week 12, Week 24, follow-up safety survey).
• This trial is a multicenter clinical trial which will be conducted at more than 5 general hospital medical institutions in the vicinity of the capital.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c

  The change in the mean level of HbA1c from baseline at week 24

  Baseline, Week 24

Secondary Outcomes (3)

• HbA1c and fasting plasma glucose

  Baseline, Week 12, Week 24

• The change in parameters of glycemic variability assessed by CGM from the Baseline at week 24

  Baseline, Week 24

• The change in lipid profile from baseline at week 12 and 24

  Baseline, Week 12, Week 24

Study Arms (3)

glimepiride

ACTIVE COMPARATOR

glimepiride 1mg monotherapy and glimepiride 2mg monotherapy

Drug: Glimepiride

alogliptin

ACTIVE COMPARATOR

alogliptin 25mg monotherapy

Drug: Alogliptin 25Mg Tab

alogliptin - pioglitazone

ACTIVE COMPARATOR

Alogliptin 25mg+pioglitazone 15mg combination

Drug: Alogliptin-Pioglitazone 25 Mg-15 Mg Oral Tablet

Interventions

Glimepiride DRUG

glimepiride

Alogliptin 25Mg Tab DRUG

alogliptin

Alogliptin-Pioglitazone 25 Mg-15 Mg Oral Tablet DRUG

alogliptin - pioglitazone

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects selected for this trial will be male and female outpatients 19 - 80 years of age (by date of birth) with type 2 diabetes and with HbA1c levels of 7.5%≤HbA1c≤10%.
• Patient's body mass index must be greater than 18 kg/m2.
• Subjects selected for the trial are patients who are starting treatment for the first time or who have failed with more than 8 weeks of treatment with 1,000 mg or the maximum tolerance dose (MTD) of metformin and want to change their medication.

You may not qualify if:

• If weight loss pills were used in the last 3 months, or hypoglycemic agents or lipid lowering agents used in a clinical trial (not including statins or ezetimibe) were used in the last 3 months.
• If the subject received systemic corticosteroid treatment or there was a change in the dosage of thyroid hormones in the 6 weeks prior to the study.
• If insulin was used within the 3 months prior to screening.
• If the patient's C-peptide level is less than 0.6 ng/mL.
• If an allergy or a hypersensitivity reaction to the target drug or its ingredients occurs.
• A medical history of type 1 diabetes; acute metabolic complications of diabetes within the past 6 months (e.g., ketoacidosis or a hyperosmolar state (coma or precoma))
• Hematological disorder
• A medical history of angioedema caused by angiotensin converting enzyme inhibitors or angiotensin receptor blockers or a medical history of treatment for diabetic gastroparesis
• If there are clear symptoms of hypothyroidism or hyperthyroidism in the opinion of the investigator.
• Myocardial infarction or percutaneous coronary intervention (stent nephrostomy or balloon nephrostomy) within the past 6 months
• Serious heart failure or a medical history of heart failure (NYHA Class III or IV heart failure)
• Heart failure, moderate to severe kidney injury (creatinine clearance of \<50 mL/min prior to screening)
• Patients with chronic hepatitis, or hepatitis B or C (not including healthy carriers of hepatitis B) or a patient with liver disease (defined as cases in which the alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or serum total bilirubin level is higher than 2.5 times the ULN)
• Hereditary complications, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (restricted to drugs including lactase)
• Cardiovascular disease or myocardial infarction; or a percutaneous transluminal coronary angioplasty or coronary artery stent nephrostomy within the past 6 months

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepiride; alogliptin

Condition Hierarchy (Ancestors)

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

Study Officials

• Sung Hee Choi

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Group A (glimepiride), Group B (alogliptin), and Group C (alogliptin-pioglitazone)

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 14, 2020
• Study Start: December 31, 2015
• Primary Completion: May 20, 2019
• Study Completion: August 31, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10