A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2
This study has been withdrawn prior to enrollment.
Sponsor:
Abbott
Collaborators:
Nuvisan
Datamap
ClinIntel
Catalent
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT02009410
First received: November 25, 2013
Last updated: June 19, 2014
Last verified: June 2014
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Purpose
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in diabetes type II
| Condition | Intervention | Phase |
|---|---|---|
|
Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2 |
Drug: Creon Drug: Creon 25000 matching Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2 |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Recovery rate of 13CO2 (carbon dioxide with stable isotope of carbon) [ Time Frame: from baseline up to the week 12 visit ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in nutritional parameters [ Time Frame: from baseline up to the week 12 visit ] [ Designated as safety issue: No ]fat soluble vitamins (D and E), retinol-binding protein, albumin, pre-albumin, magesium and calcium will be measured.
- Change in HbA1c [ Time Frame: from baseline up to the week 12 visit ] [ Designated as safety issue: No ]
- Change in quality of life assessed via a questionnaire Gastrointestinal-Quality of Life Index (GIQL) [ Time Frame: from baseline up to the week 12 visit ] [ Designated as safety issue: No ]
- Change in clinical global impression of disease symptoms [ Time Frame: from baseline up to the week 12 visit ] [ Designated as safety issue: No ]disease symptoms will be rated by the subject according a rating scale
Other Outcome Measures:
- vital signs [ Time Frame: from baseline up to the week 12 visit ] [ Designated as safety issue: Yes ]blood pressure and heart rate, body weight and BMI
- routine safety laboratory [ Time Frame: from baseline up to the week 12 visit ] [ Designated as safety issue: Yes ]Hematology, biochemistry and a urine pregnancy test will be performed
| Enrollment: | 0 |
| Study Start Date: | November 2013 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Creon |
Drug: Creon
Creon 25000 (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks
|
| Placebo Comparator: Placebo |
Drug: Creon 25000 matching Placebo
Creon 25000 placebo matching capsules (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks
|
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed Informed Consent
- BMI < 30 kg/m2
- History of type 2 diabetes mellitus as confirmed by:
- onset of diabetes after 30 years of age and
- no insulin treatment in the first year after diagnosis
- Subjects on insulin treatment or on insulin treatment in combination with oral antidiabetics
- HbA1c > 6.5% in medical history within the last 6 months despite insulin treatment
- Not previously treated with any pancreatic enzyme supplementation
Inclusion Criterion at Visit 1:
• FE-1 (fecal elastase 1) <100μg/g of stool
Inclusion Criterion at Visit 2:
• 13C MTBT of <29% 13CO2-CRR (Carbon dioxide-Cumulative Recovery Rate)
Exclusion Criteria:
- Treatment with systemic steroids for at least 3 weeks within past 6 months
- Patients with a known pancreatic exocrine insufficiency due to non-diabetic diseases, e.g., chronic pancreatitis, pancreatectomy, cystic fibrosis, celiac disease, shwachman-diamond syndrome, gastrectomy, etc.
- Any type of malignancy involving digestive tract in the last 5 years
- Any type of gastrointestinal surgery (except appendectomy and gallbladder resection)
- Short bowel syndrome
- Hemochromatosis
- Known late onset autoimmune diabetes in the adult
- Any history of drug abuse including alcohol
- Positive urine pregnancy test; lactation; females of child-bearing potential who are not using either an oral hormonal contraceptive or an intrauterine device
- Hypersensitivity to the active substance or to any of the excipients
- Intake of an experimental drug within 4 weeks prior to entry into this study
- Suspected non-compliance or non-cooperation
- History of human immunodeficiency virus (HIV) infection
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02009410
Please refer to this study by its ClinicalTrials.gov identifier: NCT02009410
Locations
| Germany | |
| Site reference no. 113456 | |
| Bochum, Germany, 44789 | |
| Site reference no. 113477 | |
| Frankfurt, Germany, 60594 | |
| Site reference no. 113476 | |
| Pohlheim, Germany, 35415 | |
| Site reference no. 113475 | |
| Ulm, Germany, 89073 | |
| Spain | |
| Site reference no. 112519 | |
| Madrid, Spain, 28034 | |
| Site reference no. 112520 | |
| Málaga, Spain, 29071 | |
| Site reference no. 112495 | |
| Santiago de Compostela, Spain, 15706 | |
| Site reference no. 112518 | |
| Segovia, Spain, 40002 | |
| Site reference no. 112496 | |
| Sevilla, Spain, 41014 | |
| Site reference no. 112517 | |
| Ávila, Spain, 05004 | |
Sponsors and Collaborators
Abbott
Nuvisan
Datamap
ClinIntel
Catalent
Investigators
| Study Director: | Suntje Sander-Struckmeier, PhD | Abbott |
More Information
No publications provided
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT02009410 History of Changes |
| Other Study ID Numbers: | M13-954, 2013-001347-31 |
| Study First Received: | November 25, 2013 |
| Last Updated: | June 19, 2014 |
| Health Authority: | United States: Food and Drug Administration Spain: Agencia Española de Medicamentos y Productos Sanitarios Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Abbott:
|
Exocrine Pancreatic Insufficiency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Exocrine Pancreatic Insufficiency Digestive System Diseases Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
Pancreatic Diseases Pancreatin Pancrelipase Gastrointestinal Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015