Effect of BKR-013 on Average Daily Glucose Levels

NCT03382015 | Completed

• 2 other identifiers: CL-2014R44DK107080-02
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of BKR-013 on average daily glucose (ADG) levels in type 2 diabetes (T2D) subjects during 28 days of either placebo or active test product administration. Subjects will serve as their own controls in this crossover design, and ADG will be compared while a subject is on active test product versus while they received placebo test product.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Average Daily Glucose Levels

  Intra-patient comparison of ADG in Part 1 vs Part 2

  After 28 days of treatment in Part 1 and in Part 2

Secondary Outcomes (2)

• Glucose >180 mg/dL

  After 28 days of treatment in Part 1 and in Part 2

• Triglycerides

  After 28 days of treatment in Part 1 and in Part 2

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Receives 28 days of active test product (BKR-013) in Part 1 of the study and receives 28 days of placebo in Part 2 of the study, following a washout period.

Other: BKR-013 or Placebo

Group 2

PLACEBO COMPARATOR

Receives 28 days of placebo in Part 1 of the study and receives 28 days of active test product (BKR-013) in Part 2 of the study, following a washout period.

Other: BKR-013 or Placebo

Interventions

BKR-013 or Placebo OTHER

Encapsulated L-glutamine

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between the ages of 18 and 70 years at the time of screening, inclusive
• Diagnosed with T2D and under the care of a healthcare professional for its management
• HbA1c 6.5-10.5%, inclusive
• Has given written informed consent to participate in this study
• Agrees to comply with all study requirements, including maintaining current diet and exercise routine and current prescription medications for the duration of the study
• Willing to wear a Continuous Glucose Monitoring (CGM) sensor continuously for 28 days during each of the two test periods
• Willing to complete two 28-day test periods (separated by a wash-out period of 21 to 35 days) and participate in the study for a total duration of up to 18 weeks.

You may not qualify if:

• Type 1 diabetes
• History of bariatric or intestinal surgery
• Active gastrointestinal disease including but not limited to irritable bowel syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), diverticulitis, gastroparesis, or chronic/frequent diarrhea or chronic/frequent constipation
• Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator
• History of significant heart disease, including congestive heart failure, prior MI, chronic atrial or ventricular fibrillation, coronary artery disease, cerebral vascular disease or other cardiovascular disease, that in the opinion of the investigator should exclude the subject from the study
• Severely uncontrolled hypertension at screening defined as a systolic blood pressure \> 180 mmHg or a diastolic blood pressure \> 110 mmHg on the average of two seated measurements after being at rest for at least 5 minutes
• Uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease
• Active significant infection as determined by the investigator
• Known allergy to L-glutamine or any of the components of the capsules
• Participation in a clinical trial and/or treatment with an investigational drug during the 30 days before screening, or within 5 half-lives of receipt of an investigational drug or twice the duration of the biological effect of any investigational drug (whichever is longer)
• Allergy or intolerance to Boost® High Protein drink
• Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan or high-frequency electrical heat (diathermy) treatment scheduled during either of the 4-week test periods that a subject is wearing CGM sensor.
• Pregnant, nursing, or trying to become pregnant
• Presence of pitting edema on physical exam
• High fiber diet

Sponsors & Collaborators

• BioKier Inc.: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• George R Szewczyk, PhD

  BioKier Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 22, 2017
• Study Start: January 9, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: August 10, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)