DiaFrail: A Short Duration Study in Older People ( DIAFRAIL Study)

NCT02484209 | Withdrawn Phase 3

• 1 other identifier: DF-07
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Many patients with type 2 diabetes are not at glycaemic goal and require additional therapy in order to reduce vascular risk and improve symptom control
2. 2.Sulphonylurea therapy is a commonly prescribed 2nd-line glucose -lowering agent and its use is recommended in major clinical guidelines for diabetes and also in the recently presented IDF (International Diabetes Federation) guidelines for older people.
3. 3.Older people with diabetes are not a homogeneous group and as many as 25% are frail.
4. 4.Frailty is a PRE-DISABILITY state but may increase the 'vulnerability' of many older people to having a fall, admission into hospital, or perhaps increasing their risk of hypoglycaemia
5. 5.As a consequence of their glucose-lowering ability, sulphonylureas may increase the risk of hypoglycaemia in older people and those who have features of frailty may be at increased risk.
6. 6.The investigators therefore need to estimate the risk of hypoglycaemia in moderately frail older subjects with type 2 diabetes who are taking sulphonylurea therapy as this is a commonly prescribed class of agent used routinely in clinical practice
7. 7.Thus, this short term project wishes to assess the frequency of hypoglycaemia in subjects with some evidence of frailty with type 2 diabetes by a series of glucose monitoring techniques with excellent research team support to minimize any safety issues. An identical study at the Second University of Naples, Italy under the supervision of Professor Giuseppe Paolisso is planned and is the second study site for this PILOT project.

Conditions

Diabetes Mellitus

Keywords

diabetes; frailty; aged; metformin; sulphonylurea; hypoglycaemia

Outcome Measures

Primary Outcomes (1)

• Difference in hypoglycaemia occurrence (mild-moderate category) between treatment arms

  The primary objective of this short PILOT study will be the evaluation of the difference (as % of variation of mild-moderate hypoglycaemic events) between the treatment arms

  16 weeks

Secondary Outcomes (3)

• Duration of Hypoglycaemia

  week 1

• Duration of Hypoglycaemia

  week 8

• Duration of Hypoglycaemia

  week 16

Study Arms (2)

Glimepiride + metformin

EXPERIMENTAL

Glimepiride (2-4mg twice daily) + metformin (1500 mg daily) (n = 10 in total) Older subjects with moderate frailty will be assigned for 16 weeks to this arm. A subgroup (n=5) will undergo 3 x 72h periods of CBGM

Drug: Glimepiride; Drug: Metformin

Metformin

ACTIVE COMPARATOR

Metformin (1500 mg daily) (n = 10 in total) Older subjects with moderate frailty will be assigned for 16 weeks to this arm. A subgroup (n=5) will undergo 3 x 72h periods of CBGM

Drug: Metformin

Interventions

Metformin DRUG

Metformin 1500 mg daily for 16 weeks

Also known as: glucophage

Metformin

Glimepiride DRUG

glimepiride 2-4 mg twice daily for 16 weeks

Also known as: Amaryl

Glimepiride + metformin

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Frail older patients with type 2 diabetes without adequate glycemic control (HbA1c \>8.0%, \>64 mmol/mol) while on metformin treatment. A previous diagnosis of type 2 diabetes mellitus will have met ADA criteria. Frailty will be identified by using the easy to use Clinical Frailty Scale (see appendix) with patients being described as point 4 (vulnerable), or point 5 (mildly frail), or point 6 (moderately frail (18).
• Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
• Patient is a male or female and \>70 years of age on the day of signing informed consent.

You may not qualify if:

• BMI \>32 Kg/m2.
• Patient has hypersensitivity or intolerance to glimepiride or any component of this medication.
• Patient treated with insulin.
• Patient with severe evidence of frailty (Clinical Frailty Scale -point 7-9)
• Patient (or carer) unable to manage SBGM (self blood glucose monitoring) and/or CBGM
• Patient routinely consumes more than 2 alcoholic drinks per day.
• Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
• Patient's glycaemia are \>300 mg/dL (\>16.7 mmol/l) at Visit 2.
• Patient has uncontrolled endocrine or metabolic disease known to influence glycaemia (i.e., secondary causes of hyperglycaemia).
• Patient has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
• Patients with an established diagnosis of dementia
• Patients with a memory disorder, those needing an interpreter, or those with severe visual impairment (unable to complete the tests)
• Patient has congestive heart failure defined by NYHA (New York Heart Association) Class III or IV.
• Patient has unstable angina pectoris.
• Patient has had a myocardial infarction, coronary artery bypass surgery. Angioplasty or uncontrolled or severe peripheral artery disease within previous 6 months

Sponsors & Collaborators

• Diabetes Frail Ltd: lead
• Merck Sharp & Dohme LLC: collaborator
• University of Campania Luigi Vanvitelli: collaborator

MeSH Terms

Conditions

Diabetes Mellitus; Frailty; Hypoglycemia

Interventions

Metformin; glimepiride

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Alan Sinclair

  Diabetes Frail Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Alan Sinclair - Principal Investigator, Director of Diabetes Frail Ltd

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 29, 2015
• Study Start: February 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: July 28, 2017

Record last verified: 2017-07