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

NCT ID: NCT03666546

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-26
• Study Completion Date: 2019-03-08

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Laevolac crystals 20 g

Lactulose crystals, oral intake, 20 g single dose

Group Type: EXPERIMENTAL

Lactulose crystals 20 g

Intervention Type: DRUG

White or almost white crystalline powder. The product will be provided in sachets to be dissolved in 250 mL water.

Laevolac crystals 30 g

Lactulose crystals, oral intake, 30 g single dose

Group Type: EXPERIMENTAL

Lactulose crystals 30 g

Intervention Type: DRUG

White or almost white crystalline powder. The products will be provided in sachets to be dissolved in 250 mL water.

Laevolac liquid 20 g

Lactulose liquid, oral intake, 20 g single dose

Group Type: EXPERIMENTAL

Lactulose liquid 20 g

Intervention Type: DRUG

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.

Laevolac liquid 30 g

Lactulose liquid, oral intake, 30 g single dose

Group Type: EXPERIMENTAL

Lactulose liquid 30 g

Intervention Type: DRUG

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.

Glucose 30 g

Glucose Monohydrate, oral intake, 33 g single dose

Group Type: ACTIVE_COMPARATOR

Glucose

Intervention Type: DRUG

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.

Water

Still water, oral intake, 250 mL single dose

Group Type: PLACEBO_COMPARATOR

Still water

Intervention Type: DRUG

250 mL still water will be used. Water from the same source will be also used to dissolve investigational and control products

Interventions

Lactulose crystals 20 g

White or almost white crystalline powder. The product will be provided in sachets to be dissolved in 250 mL water.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Laevolac crystals 20 g; Laevolac crystals 30 g; Laevolac liquid 20 g; Laevolac liquid 30 g; Glucose Monohydrate; Water

Eligibility Criteria

Inclusion Criteria

1. Patients with non-insulin requiring diabetes mellitus type 2 treated with diet and oral antidiabetics and/or Glucagon-like Peptide 1 receptor agonists

2. Age: 18-75 years

3. Female and male

4. Caucasian

5. HbA1c ≤ 7.5 %

6. Stable treatment, i.e. no change in diabetes mellitus related medication within the last 3 months

7. Mild functional constipation according to modified Rome IV criteria fulfilled for the last 3 months with symptom onset at least 6 months before study start defined as:

• approx. 3-5 bowel movements per week,
• of which 1-2 usually cause discomfort e.g., straining, lumpy or hard stools, sensation of incomplete evacuation or anorectal obstructions/blockage

8. Availability and presence in the trial unit for approx. 4 hours/ week for 4 weeks

9. Women of childbearing potential must be using a medically approved method of contraception OR women must be postmenopausal for at least 12 months prior to study entry

10. Signed informed consent form

Exclusion Criteria

1. Fasting blood glucose <4.4 mmol/L (<80 mg/dL) or >10 mmol/L (>180 mg/dL) (capillary)

2. BMI <18.5 kg/m² or ≥35 kg/m²

3. Change in body weight ≥10 % within the last 3 months

4. Smoker

5. Major medical or surgical event requiring hospitalization within the last 3 months

6. Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks

7. Presence of disease or intake of drug(s) / supplements other than antidiabetic treatment influencing digestion and absorption of carbohydrates or bowel habits (intake of laxatives in general allowed with exception see next criterion) (dietary / supplementary fibres allowed if stable dose since 1 month before study start)

8. Not willing to abstain from laxatives 2 days before the visits 1-4 and up to 24h after visits 1-4

9. Use of following medication/ supplementation within the last 4 weeks and during the study:

• Intake of medications other than antidiabetic treatment known to affect glucose tolerance e.g., steroids, protease inhibitors or antipsychotics;
• Intake of prebiotics or probiotics
• Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening)), which in the investigator's opinion would impact patient safety

10. Severe liver, renal or cardiac disease

11. Hereditary problems of galactose or fructose intolerance, lactase deficiency or glucose-galactose malabsorption

12. Suspicion of alcohol abuse (defined as an average daily intake of more than one litre of beer per day or equivalent amount of alcohol in other beverages) or drug abuse

13. Known or suspected allergy to the investigational drug(s) or other components of the study drug(s)

14. Acute inflammatory bowel disease (ulcerative colitis, Crohn's disease), gastrointestinal obstruction or subocclusive syndrome, perforations or risk of perforation in gastrointestinal tract, abdominal pain of undetermined cause

15. Known history of human immunodeficiency virus (HIV), hepatitis B and/or C

16. Pregnancy, lactation

17. Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs

18. Participation in another interventional study with an investigational drug or an investigational medical device within 30 days prior to start of study or during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Kabi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Pieber, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Head and Chair of Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University, Graz, Austria

Locations

Clinical Research Center (CRC)

Graz, , Austria

Countries

Austria

Other Identifiers

2018-002359-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Lact-004-CP4

Identifier Type: -

Identifier Source: org_study_id