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

NCT01269996 | Completed Phase 4 DMC

• 1 other identifier: CRE-2010.523
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitus; JUBILEE Study; Janumet; Lantus

Outcome Measures

Primary Outcomes (1)

• To evaluate the treatment efficacy

  The change in HbA1c in 1 year compare to baseline.

  one year

Secondary Outcomes (1)

• proportion of patients with HbA1c <6.5% in 1 year

  one year

Study Arms (2)

Metformin followed by gliclazide and protaphane

ACTIVE COMPARATOR

Drug: Janumet, Lantus; Drug: metformin, gliclazide, protaphane

Janumet followed by Lantus insulin injection

ACTIVE COMPARATOR

Drug: Janumet, Lantus; Drug: metformin, gliclazide, protaphane

Interventions

Janumet, Lantus DRUG

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.

Janumet followed by Lantus insulin injection; Metformin followed by gliclazide and protaphane

metformin, gliclazide, protaphane DRUG

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.

Janumet followed by Lantus insulin injection; Metformin followed by gliclazide and protaphane

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 to 80 years old at Visit 1.
• Male or female of Chinese ethnicity.
• Type 2 diabetic patients who are drug naïve with HbA1c ranged between 7.0% to 11.0%.
• 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.
• Patient agrees to provide permission to obtain all medical records necessary for complete data ascertainment during study and follow-up period.

You may not qualify if:

• Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
• 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.
• 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.
• 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.
• 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.
• Any history of cardiovascular disease, stroke or peripheral vascular disease.
• Any symptoms of ischaemic heart disease like angina.
• Renal transplant patients.
• 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.
• 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.
• 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.
• Patient has a known history of hypersensitivity, intolerance or any contraindication to either metformin, sulfonylurea, DPP-IV inhibitor or insulin.
• Active and uncontrolled thyroid diseases or active endocrine diseases like Cushing's syndrome or acromegaly.
• 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.
• Any medical illness or condition as judged by the investigators as ineligible to participate the study.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination; Insulin Glargine; Metformin; Gliclazide; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Sitagliptin Phosphate; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Drug Combinations; Pharmaceutical Preparations; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Benzenesulfonamides; Sulfonamides; Amides; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Proinsulin

Study Officials

• Juliana CN CHAN, FRCP, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2011
• First Posted: January 5, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: February 1, 2015
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

HK (1)