NCT03666546

Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2

Blood Glucose Response After Oral Intake of Lactulose (Laevolac®) in Mildly Constipated Patients With Diabetes Mellitus Type 2

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Fresenius Kabi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to investigate whether lactulose, given orally as powder or liquid, increases blood glucose levels in patients with diabetes mellitus type 2. The dose of lactulose given in the study is normally used for treatment of constipation.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Lactulose crystals 20 g	White or almost white crystalline powder. The product will be provided in sachets to be dissolved in 250 mL water.
DRUG	Lactulose crystals 30 g	White or almost white crystalline powder. The products will be provided in sachets to be dissolved in 250 mL water.
DRUG	Lactulose liquid 20 g	Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
DRUG	Lactulose liquid 30 g	Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
DRUG	Glucose	White crystalline powder. To standardise for 30 g glucose, 33 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water.
DRUG	Still water	250 mL still water will be used. Water from the same source will be also used to dissolve investigational and control products

Timeline

• Start date: 2018-11-26
• Primary completion: 2019-03-05
• Completion: 2019-03-08
• First posted: 2018-09-12
• Last updated: 2019-04-12

Locations

1 site across 1 country: Austria