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The Copenhagen Insulin and Metformin Therapy Trial (CIMT)

Primary Purpose

Type 2 Diabetes, Atherosclerosis, Arteriosclerosis

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
metformin
insulin detemir
insulin aspart + insulin aspart protamin
Insulin aspart
Sponsored by
Steno Diabetes Center Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring carotid, intima, media, thickness, insulin, metformin

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females over 30 years of age
  • Type 2 diabetes
  • Body mass index (BMI): 25.0-39.9 kg/m2
  • HbA1c above 7.5 %
  • Antidiabetic tablet-treatment during 1 year minimum AND / OR
  • Insulin treatment during a minimum of 3 months
  • Negative pregnancy test
  • Signed, informed consent

Exclusion Criteria:

  • MI, coronary revascularization, TCI,or apoplexy within the last 3 months
  • TCI with verified stenosis of above 70%
  • Heart failure (NYHA class III or IV)
  • Former cancer patient, unless disease-free period of more than 5 years
  • estimated creatinine clearance < 60 ml/min Liver disease
  • Alcohol abuse
  • Drug abuse
  • Retinopathy with on-going laser treatment at start of study
  • Other acute or chronic serious disease leading to hypoxia
  • Pregnant or breastfeeding women
  • Women of child-bearing potential, not using contraceptives
  • Allergy to medication used in the study
  • Incapable of understanding the nature of the informed consent

Sites / Locations

  • Rigshospitalet
  • Bispebjerg Hospital
  • Frederiksberg Hospital
  • Gentofte Sygehus
  • Steno Diabetes Center
  • Herlev Hospital
  • Hillerod Sygehus
  • Hvidovre Hospital
  • Køge Sygehus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

1M

1P

2M

2P

3M

3P

Arm Description

Metformin + Levemir x1

Placebo + Levemir x1

metformin + NovoMix

Placebo + NovoMix

Metformin + 4x therapy

Placebo + 4x therapy

Outcomes

Primary Outcome Measures

Carotid intima media thickness

Secondary Outcome Measures

adverse events

Full Information

First Posted
April 8, 2008
Last Updated
February 2, 2014
Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Hvidovre University Hospital, Hillerod Hospital, Denmark, Frederiksberg University Hospital, University Hospital, Gentofte, Copenhagen, Rigshospitalet, Denmark, Bispebjerg Hospital, Herlev Hospital, Zealand University Hospital, Copenhagen Trial Unit, Center for Clinical Intervention Research, Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00657943
Brief Title
The Copenhagen Insulin and Metformin Therapy Trial
Acronym
CIMT
Official Title
The Effect of Metformin Versus Placebo, Including Three Insulin-Analogue Regimens With Variating Postprandial Glucose Regulation, on CIMT in T2DM Patients - A Randomized, Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Hvidovre University Hospital, Hillerod Hospital, Denmark, Frederiksberg University Hospital, University Hospital, Gentofte, Copenhagen, Rigshospitalet, Denmark, Bispebjerg Hospital, Herlev Hospital, Zealand University Hospital, Copenhagen Trial Unit, Center for Clinical Intervention Research, Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Type 2 Diabetes Mellitus patients (T2DM) have an increased mortality rate due to macrovascular disease. The primary objective of the study is to evaluate the effect of an 18-month treatment with metformin versus placebo in combination with one of three insulin analogue regimens following a treat-to-target principle. The primary outcome measure is change in wall thickness of the carotic arteries(CIMT)measured by ultrasound. A total of 900 patients with T2DM and HbA1c above 7.5% will be included.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Atherosclerosis, Arteriosclerosis
Keywords
carotid, intima, media, thickness, insulin, metformin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1M
Arm Type
Experimental
Arm Description
Metformin + Levemir x1
Arm Title
1P
Arm Type
Placebo Comparator
Arm Description
Placebo + Levemir x1
Arm Title
2M
Arm Type
Experimental
Arm Description
metformin + NovoMix
Arm Title
2P
Arm Type
Placebo Comparator
Arm Description
Placebo + NovoMix
Arm Title
3M
Arm Type
Experimental
Arm Description
Metformin + 4x therapy
Arm Title
3P
Arm Type
Placebo Comparator
Arm Description
Placebo + 4x therapy
Intervention Type
Drug
Intervention Name(s)
metformin
Other Intervention Name(s)
glucophage
Intervention Description
metformin tablets 2 g x 2
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Other Intervention Name(s)
Levemir
Intervention Description
insulin as requested
Intervention Type
Drug
Intervention Name(s)
insulin aspart + insulin aspart protamin
Other Intervention Name(s)
novomix
Intervention Description
insulin as requested
Intervention Type
Drug
Intervention Name(s)
Insulin aspart
Other Intervention Name(s)
NovoRapid
Intervention Description
insulin as requested
Primary Outcome Measure Information:
Title
Carotid intima media thickness
Time Frame
18 months
Secondary Outcome Measure Information:
Title
adverse events
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females over 30 years of age Type 2 diabetes Body mass index (BMI): 25.0-39.9 kg/m2 HbA1c above 7.5 % Antidiabetic tablet-treatment during 1 year minimum AND / OR Insulin treatment during a minimum of 3 months Negative pregnancy test Signed, informed consent Exclusion Criteria: MI, coronary revascularization, TCI,or apoplexy within the last 3 months TCI with verified stenosis of above 70% Heart failure (NYHA class III or IV) Former cancer patient, unless disease-free period of more than 5 years estimated creatinine clearance < 60 ml/min Liver disease Alcohol abuse Drug abuse Retinopathy with on-going laser treatment at start of study Other acute or chronic serious disease leading to hypoxia Pregnant or breastfeeding women Women of child-bearing potential, not using contraceptives Allergy to medication used in the study Incapable of understanding the nature of the informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Almdal, MD DMSc
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Frederiksberg Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Gentofte Sygehus
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark
Facility Name
Steno Diabetes Center
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2830
Country
Denmark
Facility Name
Hillerod Sygehus
City
Hillerod
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Køge Sygehus
City
Koge
ZIP/Postal Code
4600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
32979921
Citation
Hansen CS, Lundby-Christiansen L, Tarnow L, Gluud C, Hedetoft C, Thorsteinsson B, Hemmingsen B, Wiinberg N, Sneppen SB, Lund SS, Krarup T, Madsbad S, Almdal T, Carstensen B, Jorgensen ME; CIMT study group. Metformin may adversely affect orthostatic blood pressure recovery in patients with type 2 diabetes: substudy from the placebo-controlled Copenhagen Insulin and Metformin Therapy (CIMT) trial. Cardiovasc Diabetol. 2020 Sep 26;19(1):150. doi: 10.1186/s12933-020-01131-3.
Results Reference
derived
PubMed Identifier
30027438
Citation
Nordklint AK, Almdal TP, Vestergaard P, Lundby-Christensen L, Boesgaard TW, Breum L, Gade-Rasmussen B, Sneppen SB, Gluud C, Hemmingsen B, Jensen T, Krarup T, Madsbad S, Mathiesen ER, Perrild H, Tarnow L, Thorsteinsson B, Vestergaard H, Lund SS, Eiken P. The effect of metformin versus placebo in combination with insulin analogues on bone mineral density and trabecular bone score in patients with type 2 diabetes mellitus: a randomized placebo-controlled trial. Osteoporos Int. 2018 Nov;29(11):2517-2526. doi: 10.1007/s00198-018-4637-z. Epub 2018 Jul 19.
Results Reference
derived
PubMed Identifier
26916685
Citation
Lundby-Christensen L, Vaag A, Tarnow L, Almdal TP, Lund SS, Wetterslev J, Gluud C, Boesgaard TW, Wiinberg N, Perrild H, Krarup T, Snorgaard O, Gade-Rasmussen B, Thorsteinsson B, Roder M, Mathiesen ER, Jensen T, Vestergaard H, Hedetoft C, Breum L, Duun E, Sneppen SB, Pedersen O, Hemmingsen B, Carstensen B, Madsbad S. Effects of biphasic, basal-bolus or basal insulin analogue treatments on carotid intima-media thickness in patients with type 2 diabetes mellitus: the randomised Copenhagen Insulin and Metformin Therapy (CIMT) trial. BMJ Open. 2016 Feb 25;6(2):e008377. doi: 10.1136/bmjopen-2015-008377.
Results Reference
derived
PubMed Identifier
26916684
Citation
Lundby-Christensen L, Tarnow L, Boesgaard TW, Lund SS, Wiinberg N, Perrild H, Krarup T, Snorgaard O, Gade-Rasmussen B, Thorsteinsson B, Roder M, Mathiesen ER, Jensen T, Vestergaard H, Hedetoft C, Breum L, Duun E, Sneppen SB, Pedersen O, Hemmingsen B, Carstensen B, Madsbad S, Gluud C, Wetterslev J, Vaag A, Almdal TP. Metformin versus placebo in combination with insulin analogues in patients with type 2 diabetes mellitus-the randomised, blinded Copenhagen Insulin and Metformin Therapy (CIMT) trial. BMJ Open. 2016 Feb 25;6(2):e008376. doi: 10.1136/bmjopen-2015-008376.
Results Reference
derived

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The Copenhagen Insulin and Metformin Therapy Trial

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