Study of KD026 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus

NCT02434744 | Completed Phase 2

• 1 other identifier: KD026-201
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 10

Brief Summary

This study will compare the safety, tolerability and efficacy of the combination of KD026 and metformin compared to placebo and metformin on improving glycemic control in patients with type 2 diabetes mellitus.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Experiencing Adverse Events as a Measure of Safety, Tolerability, and Efficacy

  To assess the safety, tolerability, and efficacy (as measured by a 0.5%-1.5% decrease of HbA1c) of different dosages and dosing regimens of a combination of KD026 and metformin compared to placebo and metformin when administered for 3 months to subjects with type 2 diabetes mellitus

  12 Weeks

Secondary Outcomes (11)

• Changes in Fasting Plasma Glucose (FPG)

  12 Weeks

• Changes in Insulin

  12 Weeks

• Changes in HOMA-IR

  12 Weeks

• Changes in Body Weight

  12 Weeks

• Changes in AUC

  12 Weeks

Study Arms (8)

Cohort 1 100 mg KD026 BID

EXPERIMENTAL

100 mg KD026 twice a day (BID) in combination with Metformin for 12 weeks

Drug: KD026; Drug: Metformin

Cohort 2 150 mg KD026 BID

EXPERIMENTAL

150 mg KD026 BID in combination with Metformin for 12 weeks

Drug: KD026; Drug: Metformin

Cohort 3 200 mg KD026 BID

EXPERIMENTAL

200 mg KD026 BID in combination with Metformin for 12 weeks

Drug: KD026; Drug: Metformin

Cohort 4 100 mg KD026 TID

EXPERIMENTAL

100 mg KD026 three times a day (TID) in combination with Metformin for 12 weeks

Drug: KD026; Drug: Metformin

Cohort 1 Placebo

PLACEBO COMPARATOR

Matched Placebo Dose BID in combination with Metformin for 12 weeks

Drug: Placebo; Drug: Metformin

Cohort 2 Placebo

PLACEBO COMPARATOR

Matched Placebo Dose BID in combination with Metformin for 12 weeks

Drug: Placebo; Drug: Metformin

Cohort 3 Placebo

PLACEBO COMPARATOR

Matched Placebo Dose BID in combination with Metformin for 12 weeks

Drug: Placebo; Drug: Metformin

Cohort 4 Placebo

PLACEBO COMPARATOR

Matched Placebo Dose TID in combination with Metformin for 12 weeks

Drug: Placebo; Drug: Metformin

Interventions

KD026 DRUG

Dosed in combination

Also known as: SLx-4090

Cohort 1 100 mg KD026 BID; Cohort 2 150 mg KD026 BID; Cohort 3 200 mg KD026 BID; Cohort 4 100 mg KD026 TID

Placebo DRUG

Dosed in combination

Cohort 1 Placebo; Cohort 2 Placebo; Cohort 3 Placebo; Cohort 4 Placebo

Metformin DRUG

Drug prescribed by each subject's prescribing physician

Cohort 1 100 mg KD026 BID; Cohort 1 Placebo; Cohort 2 150 mg KD026 BID; Cohort 2 Placebo; Cohort 3 200 mg KD026 BID; Cohort 3 Placebo; Cohort 4 100 mg KD026 TID; Cohort 4 Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have type 2 diabetes, with finger stick HbA1c ≥ 7.0% and ≤ 11.0% at screening visit, and HbA1c via venipuncture ≥ 7.0% and ≤ 11.0 % at the Qualification visit
• Have been on metformin for at least 12 weeks prior to screening visit and the metformin dose is not expected to change during the 4-week run-in period
• Have a BMI of ≥ 27 kg/m2 and ≤ 45 kg/m2
• Men, post-menopausal women (defined as not having a menstrual period for at least 1 year), surgically sterile women (for at least 1 year), or women of childbearing potential with a negative pregnancy test within the last 24 hours
• Women of childbearing potential and men whose partners are of childbearing potential must agree to use two forms of accepted methods of contraception during the course of the study and for 1 month after their last dose of study drug. Effective birth control includes (a) IUD plus one barrier method; (b) on stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method; (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); or (d) a vasectomized partner

You may not qualify if:

• Have type 1 diabetes
• Taking antidiabetic medications other than or in addition to metformin
• Have fasting plasma glucose \> 270 mg/dL at screening visit
• Have a serum creatinine ≥1.7 mg/dL or glomerular filtration rate \<60 mL/min at screening visit
• Have a history of diabetic retinopathy
• Uncontrolled high blood pressure
• Have a history of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) \>2.0 × the upper limit of normal (ULN) at screening visit.
• Have a history of a malignant cancer (other than basal cell, localized cervical, or squamous cell carcinoma of the skin that has been removed)
• Have a history or presence of gastrointestinal (GI) disease or major gastrointestinal surgery that, in the opinion of the investigator, could interfere with drug absorption
• Currently using any of prohibited medications that cannot be stopped
• Abuse alcohol (defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units \[1 unit is equivalent to a half pint of beer, 1 serving of hard liquor, or one glass of wine\]
• History or presence of drug abuse according to Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) criteria within the 2 years prior to screening visit
• Have a 12-lead ECG at screening visit that, in the opinion of the investigator, have abnormalities that may compromise safety in this study, including a QTc(F) interval (QT interval data corrected using Fridericia's formula) of \> 450 msec
• Have a clinically significant abnormal laboratory result including thyroid-stimulating hormone (TSH) \>1.5 × ULN at screening visit
• Have a positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody/virus (HCV) or human immunodeficiency virus (HIV) antibodies at screening visit or a documented history of a positive result

Sponsors & Collaborators

• Response Pharmaceuticals: lead

Study Sites (10)

Achieve Clinical Research, LLC

Birmingham, Alabama, 35216, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Infosphere Clinical Research, Inc

West Hills, California, 91307, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

Med Research of Florida, LLC

Miami, Florida, 33186, United States

Location

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Clinical Research Associates of Tidewater

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

6-(4'-trifluoromethyl-6-methoxybiphenyl-2-ylcarboxamido)-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid phenyl ester; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 5, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 18, 2023

Record last verified: 2023-04

Locations

US (10)