JanUmet Before Insulin Lantus In Eastern Population Evaluation Program (JUBILEE) In Type 2 Diabetic Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Chinese University of Hong Kong.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01269996
First received: January 4, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

To evaluate the efficacy and safety of a new treatment regimen of metformin plus sitagliptin (Janumet) followed by a long-acting basal insulin (Lantus) treatment compared to the usual treatment regimen of metformin followed by sulfonylurea and intermediate-acting basal insulin in Type 2 Diabetes Mellitus patients.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Janumet, Lantus
Drug: metformin, gliclazide, protaphane
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: JanUmet Before Insulin Lantus In Eastern Population Evaluation Program (JUBILEE) In Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • To evaluate the treatment efficacy [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    The change in HbA1c in 1 year compare to baseline.


Secondary Outcome Measures:
  • proportion of patients with HbA1c <6.5% in 1 year [ Time Frame: one year ] [ Designated as safety issue: Yes ]

    Secondary Outcome Measure: The proportion of patients with HbA1c <6.5% in 1 year.

    Other outcome measures: a)The change in body weight compare to baseline. b)Frequency of hypoglycaemia . Hypoglycemia is defined according to the ADA definitions and classifications of hypoglycaemia.



Estimated Enrollment: 160
Study Start Date: January 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin followed by gliclazide and protaphane Drug: Janumet, Lantus

In this multicentre, randomized, open-label prospective study. Recruited patients will be randomized to one of the two treatment groups. Treatment efficacy and safety in terms of HbA1c control and hypoglycemic events will be evaluated.

Treatment groups:

Group 1 - Metformin followed by Sulfonylurea (Gliclazide) and supplementary intermediate-acting insulin (Protaphane) injection.

Group 2 - Janumet followed by Lantus insulin injection.

Drug: metformin, gliclazide, protaphane

In this multicentre, randomized, open-label prospective study. Recruited patients will be randomized to one of the two treatment groups. Treatment efficacy and safety in terms of HbA1c control and hypoglycemic events will be evaluated.

Treatment groups:

Group 1 - Metformin followed by Sulfonylurea (Gliclazide) and supplementary intermediate-acting insulin (Protaphane) injection.

Group 2 - Janumet followed by Lantus insulin injection.

Active Comparator: Janumet followed by Lantus insulin injection Drug: Janumet, Lantus

In this multicentre, randomized, open-label prospective study. Recruited patients will be randomized to one of the two treatment groups. Treatment efficacy and safety in terms of HbA1c control and hypoglycemic events will be evaluated.

Treatment groups:

Group 1 - Metformin followed by Sulfonylurea (Gliclazide) and supplementary intermediate-acting insulin (Protaphane) injection.

Group 2 - Janumet followed by Lantus insulin injection.

Drug: metformin, gliclazide, protaphane

In this multicentre, randomized, open-label prospective study. Recruited patients will be randomized to one of the two treatment groups. Treatment efficacy and safety in terms of HbA1c control and hypoglycemic events will be evaluated.

Treatment groups:

Group 1 - Metformin followed by Sulfonylurea (Gliclazide) and supplementary intermediate-acting insulin (Protaphane) injection.

Group 2 - Janumet followed by Lantus insulin injection.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients aged 18 to 80 years old at Visit 1.
  2. Male or female of Chinese ethnicity.
  3. Type 2 diabetic patients who are drug naïve with HbA1c ranged between 7.0% to 11.0%.
  4. Type 2 diabetic patients who are on single oral hypoglycaemic drug treatment or insulin treatment of duration less than 6 months are eligible after at least 3 months of washout period with diet control only prior to Visit 1 and satisfy the inclusion criteria of HbA1c ranged between 7.0% to 11.0%.
  5. Patient understands the study procedures, alternative treatments available, and the risks involved with the study, and voluntarily agrees to participate by providing written informed consent.
  6. Patient agrees to provide permission to obtain all medical records necessary for complete data ascertainment during study and follow-up period.

Exclusion Criteria:

  1. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
  2. Patients with HbA1c 9% to 11% who have severe symptoms and showing signs of decompensation (e.g. rapid weight loss and ketonuria) due to hyperglycaemia.
  3. On anti-obesity drugs 12 weeks prior to informed consent, patient in a weight loss program or intends to be involved in weight loss intervention outside that prescribed by the study.
  4. Patient has renal impairment defined as serum creatinine equal to/more than 123 umol/l (1.4mg/dL) in female and serum creatinine equal to/more than 132 umol/l (1.5mg/dL) in male.
  5. Significant liver impairment (ALT equal to /more than 2 times upper limit of normal range) or a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, liver cirrhosis or symptomatic gallbladder disease.
  6. Any history of cardiovascular disease, stroke or peripheral vascular disease.
  7. Any symptoms of ischaemic heart disease like angina.
  8. Renal transplant patients.
  9. Active malignant disease. Patients with malignant disease who have been successfully treated and disease-free for at least 5 years are eligible. However, patients with a history of leukaemia, lymphoma, aplastic anaemia, myeloproliferative or myelodysplastic disease, thrombocytopenia, malignant melanoma, or renal cell carcinoma are ineligible for the study regardless of the time since treatment.
  10. Patient has medical history that indicates a life expectancy of less than 5 years or might limit the individual's ability to take trial treatments for the duration of the study.
  11. Patient has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose a risk to the patient, make participation not in the patient's best interest, confound the results of the study (e.g. if patient cannot comply with requirements of the study), or interfere with the patient's participation for the full duration of the study.
  12. Patient has a known history of hypersensitivity, intolerance or any contraindication to either metformin, sulfonylurea, DPP-IV inhibitor or insulin.
  13. Active and uncontrolled thyroid diseases or active endocrine diseases like Cushing's syndrome or acromegaly.
  14. Pre-menopausal women (last menstruation 1 year prior to signing informed consent) who: are nursing or pregnant, or are of child-bearing potential and are not practicing an acceptable and reliable contraceptive methods, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra-uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
  15. Any medical illness or condition as judged by the investigators as ineligible to participate the study.
  16. Special population, e.g. prisoner, mentally disabled, persons with psychiatric disorders and investigators' student or employees.
  17. Patient is currently participating in or has participated in another study with an investigational compound or device within the prior 12 weeks of screening or signing the informed consent and does not agree to refrain from participating in any other study while participating in this study.
  18. Patient has undergone surgery within the prior 12 weeks or has major surgery planned during the study.
  19. Patient is on or is likely to require treatment with equal to/ more than 14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.

    Note: Inhaled, nasal, and topical corticosteroids are permitted.

  20. Patient has a clinically significant laboratory or ECG abnormality which, in the opinion of the investigator, exposes the patient to risk by enrolling in the study.
  21. History of drug abuse or alcohol abuse. History of recreational or illicit drugs used. Alcohol abuse includes heavy alcohol intake as defined by more than 2 drinks per day or more than 14 drinks per week, or binge drinking.
  22. Patient has a clinically significant haematological disorder (e.g., aplastic anaemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia, thalassaemia or thalassaemia trait).
  23. Blood donation 3 months prior to the start of the study and during the whole study period.
  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: NCT01269996

Contacts
Contact: Juliana CN CHAN, FRCP, MD +852 2632 3138 jchan@cuhk.edu.hk
Contact: Vanessa WS NG, MRCP +852 2632 3129 ngwsvanessa@hotmail.com

Locations
Hong Kong
Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong Not yet recruiting
Hong Kong, Hong Kong
Contact: Juliana CN CHAN, FRCP, MD    +852 2632 3138    jchan@cuhk.edu.hk   
Contact: Vanessa WS NG, MRCP    +852 2632 3129    ngwsvanessa@hotmail.com   
Principal Investigator: Juliana CN Chan, FRCP, MD         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Juliana CN CHAN, FRCP, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Professor Juliana Chung Ngor CHAN, Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01269996     History of Changes
Other Study ID Numbers: CRE-2010.523
Study First Received: January 4, 2011
Last Updated: January 4, 2011
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
type 2 diabetes mellitus
JUBILEE Study
Janumet
Lantus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Gliclazide
Insulin
Insulin, Globin Zinc
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014