Evaluate Effects of Sprinkled Format REDUCOSE in a Carbohydrate-rich, Mixed Meal on Post-prandial Glycemia

Not Applicable

Completed

• Conditions: Dietary Supplement
• Interventions: Other: Active comparator; Other: Reference control

• Registration Number: NCT04877366
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

This is a mechanistic, single-center, double-blind, placebo- and active-controlled, three-time-period, crossover study to evaluate the effect of sprinkled format REDUCOSE compared to placebo (double-blind; confirmative) and active control (open-label; acarbose - explorative) on post prandial glycemia in Asian patients with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-07
• Study Start: 2021-07-21
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Willing and able to sign written informed consent prior to study entry.
• Participants who self-identify as Asian; male or female, >18 years of age.
• Established diagnosis of type 2 diabetes (documented by either HbA1c 6.5 - 10.0% or a documented diagnosis of type 2 diabetes).
• Treatment naïve or on active therapy with metformin at a daily dose of 500-3000 mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
• Participants must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
• Participants must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males.

Exclusion Criteria

• Fasting plasma glucose >220 mg/dl at screening.
• Impaired kidney function, eGFR of <60 mL/min/1.73 m2 at screening.
• BMI >35 kg/m2.
• Weight ≤ 50 kg.
• Elevated liver transaminase > 3 ULN at screening.
• Ongoing or recent (i.e. < 3 month) treatment with any oral or injectable glucose-lowering drug other than metformin.
• Ongoing or recent (i.e. < 3 month) injectable insulin therapy.
• Ongoing or recent (i.e. < 3 month) weight loss interventions (e.g. dietary weight loss programs) or any history of bariatric surgery or any documented weight loss >5% within previous 6 months.
• Ongoing or recent (i.e. < 3 month) treatment with anorectic drugs, systemic steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption.
• Major medical/surgical event requiring hospitalization in the last 3 months.
• Known allergy and intolerance to product components or paracetamol.
• Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
• Are unable to comply with protocol procedures in the opinion of the investigator.
• Have a hierarchical link with the research team members.
• Positive pregnancy test or breast-feeding at screening.
• Participants who have been dosed in another clinical study with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening.
• Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Participants must also agree to not donate blood within 8 weeks after their last visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ARM C: Placebo C: Acarbose	Active comparator	Acarbose 100 mg tablet (provided in open-label format)
ARM B: Placebo B: Standard Meal	Reference control	A placebo matching to the test product will be used as control

Primary Outcome Measures

Name	Time	Method
Post-prandial glycemic excursion (ARMs A and B)	0 ,15, 30, 60, 120, and 180 minutes.	Incremental area under the curve post-prandial glycemic excursion (iAUC 0-1h, iAUC 0-2h, iAUC 0-3h).

Secondary Outcome Measures

Name	Time	Method
Plasma glucose Tmax (ARMs A and B)	0 ,15, 30, 60, 120, and 180 minutes.	Plasma glucose Tmax
Plasma interleukin-6 (ARMs A and B)	0 ,15, 30, 60, 120, and 180 minutes.	Plasma interleukin-6 (IL-6) (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
Total glucose (All ARMS)	0 ,15, 30, 60, 120, and 180 minutes.	Total glucose AUC 0-1h (tAUC 0-1h, tAUC 0-2h, tAUC 0-3h)
Plasma GLP-1 (ARMs A and B)	0 ,15, 30, 60, 120, and 180 minutes.	Plasma GLP-1 (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
Serum insulin (All ARMs)	0 ,15, 30, 60, 120, and 180 minutes.	Serum insulin (iAUC 0-3h, iCmax, Tmax, tAUC 0-3h)
Plasma GIP (ARMs A and B)	0 ,15, 30, 60, 120, and 180 minutes.	Plasma GIP (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h)
2h post-prandial glucose levels (ARMs A and B)	0 ,15, 30, 60, and 120 minutes.	Incremental area under the curve 2h post-prandial glucose levels
Plasma glucose iCmax (ARMs A and B)	0 ,15, 30, 60, 120, and 180 minutes.	Plasma glucose iCmax
Plasma glucose AUC (ARMs A and B)	0 ,15, 30, 60, 120, and 180 minutes.	protocol states (iAUC 0-3h, tAUC 0-3h)
Gastric emptying (ARMs A and B)	0 ,15, 30, 60, 120, and 180 minutes.	Gastric emptying (iAUC 0-1h, tAUC 0-1h, iAUC 0-3h, tAUC 0-3h, Cmax and Tmax for paracetamol)
Matsuda Index (ARMs A and B)	0, 30, 60, and 120 minutes.	Matsuda Index

Trial Locations

Locations (2)

Orange County Research Center; 🇺🇸 Tustin, California, United States

Temasek Polytechnic; 🇸🇬 Singapore, Singapore