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

PHASE4CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 26, 2018

Primary Completion Date

March 5, 2019

Study Completion Date

March 8, 2019

Conditions
Diabetes Mellitus, Type 2
Interventions
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

Trial Locations (1)

A-8036

Clinical Research Center (CRC), Graz

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Fresenius Kabi

INDUSTRY