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Study · Non-randomized trial · n = 988 · 2012

11 results

Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets.

DeVries JH, Bain SC, Rodbard HW, Seufert J, D'Alessio D, Thomsen AB, Zychma M, Rosenstock J

Diabetes care14 May 2012Cited by 116 (Europe PMC)

PMID22584132 (opens in a new tab)PMCIDPMC3379583 (opens in a new tab)DOI10.2337/dc11-1928 (opens in a new tab)PepBankPUB-22584132
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study11

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In adults with type 2 diabetes, 167 of 988 participants (17%) withdrew during the 12-week liraglutide run-in.

    In plain wordsIn adults with type 2 diabetes, 17% of people stopped during the first 12 weeks of liraglutide treatment.

    Peptide
    Liraglutide
    Outcome
    Not applicableWithdrawal during run-in
    Study

    n = 988

    Outcome group
    Adverse events · Whole body
    Studied dose
    1.8 mg/day · 12 weeksAs given in this study (human).

    Measurements

    Withdrawals
    17%
    run-in

    Source sentences

    Summary
    During run-in, 167 of 988 (17%) withdrew
    2 context sentences
    Summary · context
    In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run-in).
    Summary · context
    Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161).
  2. 02HumanNon-randomized trialEfficacy outcome

    In adults with type 2 diabetes uncontrolled on metformin, 61% of those completing a 12-week liraglutide run-in reached A1C below 7%.

    In plain wordsIn adults with type 2 diabetes, most people reached the A1C target after 12 weeks of adding liraglutide to metformin.

    Peptide
    Liraglutide
    Outcome
    IncreaseProportion reaching A1C <7% during run-in
    Study

    n = 821

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.8 mg/day · 12 weeksAs given in this study (human).

    Measurements

    Proportion with A1C <7%
    61%
    completers of run-in

    Source sentences

    Summary
    Of 821 participants completing the run-in, 61% (n = 498) achieved A1C <7%
    2 context sentences
    Summary · context
    In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run-in).
    Summary · context
    Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161).
  3. 03HumanNon-randomized trialEfficacy outcome

    In adults with type 2 diabetes who reached A1C below 7% during liraglutide run-in, mean A1C fell by 1.3% from 7.7% at start.

    In plain wordsIn adults with type 2 diabetes who reached the target, A1C fell by 1.3% after 12 weeks of liraglutide added to metformin.

    Peptide
    Liraglutide
    Outcome
    DecreaseA1C change in participants who reached A1C <7%
    Study

    n = 498

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.8 mg/day · 12 weeksAs given in this study (human).

    Measurements

    A1C mean change
    −1.3%
    A1C <7% achievers

    Source sentences

    Summary
    Of 821 participants completing the run-in, 61% (n = 498) achieved A1C <7% (mean change -1.3% from 7.7% at start)
    2 context sentences
    Summary · context
    In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run-in).
    Summary · context
    Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161).
  4. 04HumanNon-randomized trialEfficacy outcome

    In adults with type 2 diabetes who did not reach A1C below 7% during liraglutide run-in, mean A1C fell by 0.6% from 8.3% at start.

    In plain wordsIn adults with type 2 diabetes who missed the target, A1C still fell by 0.6% after 12 weeks of liraglutide added to metformin.

    Peptide
    Liraglutide
    Outcome
    DecreaseA1C change in participants who did not reach A1C <7%
    Study

    n = 323

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.8 mg/day · 12 weeksAs given in this study (human).

    Measurements

    A1C mean change
    −0.6%
    A1C >=7% at end of run-in

    Source sentences

    Summary
    whereas 39% (n = 323) did not (-0.6% from 8.3% at start).
    2 context sentences
    Summary · context
    In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run-in).
    Summary · context
    Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161).
  5. 05HumanNon-randomized trialSafety outcome

    In adults with type 2 diabetes, 46% of run-in withdrawals on liraglutide were due to gastrointestinal adverse events.

    In plain wordsIn adults with type 2 diabetes, stomach and gut side effects caused 46% of the early drop-outs on liraglutide.

    Peptide
    Liraglutide
    Outcome
    Not applicableGastrointestinal adverse events as reason for withdrawal
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.8 mg/day · 12 weeksAs given in this study (human).

    Measurements

    Withdrawals due to GI adverse events
    46%
    of withdrawals

    Source sentences

    Summary
    During run-in, 167 of 988 (17%) withdrew; 46% of these due to gastrointestinal adverse events.
    2 context sentences
    Summary · context
    In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run-in).
    Summary · context
    Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161).
  6. 06HumanNon-randomized trialEfficacy outcome

    In adults with type 2 diabetes, mean weight decreased by 3.5 kg during the liraglutide run-in.

    In plain wordsIn adults with type 2 diabetes, weight fell by about 3.5 kg during 12 weeks of liraglutide added to metformin.

    Peptide
    Liraglutide
    Outcome
    DecreaseBody weight change during run-in
    Study

    n: not reported in source

    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    1.8 mg/day · 12 weeksAs given in this study (human).

    Measurements

    Mean weight change
    −3.5 kg
    run-in

    Source sentences

    Summary
    Mean weight decreased by 3.5 kg during run-in
    2 context sentences
    Summary · context
    In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run-in).
    Summary · context
    Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161).

Studies that did not test the peptide alone5

In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Liraglutide.

  1. 07HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes on metformin plus liraglutide, adding insulin detemir lowered A1C more than continuing without it at week 26.

    In plain wordsIn adults with type 2 diabetes on metformin and liraglutide, adding insulin detemir lowered A1C more than not adding it.

    Peptide
    Liraglutide
    Outcome
    DecreaseA1C change with insulin detemir versus none (liraglutide background)
    Study

    n = 319

    Comparator
    No insulin detemir
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight

    Measurements

    A1C change
    −0.5%
    with insulin detemir
    Estimated treatment difference
    −0.52%
    95% CI -0.68 to -0.36

    Source sentences

    Summary
    At week 26, A1C decreased further, by 0.5% (from 7.6% at randomization) with insulin detemir (n = 162) versus 0.02% increase without insulin detemir (n = 157) to 7.1 and 7.5%, respectively (estimated treatment difference -0.52 [95% CI -0.68 to -0.36]; P < 0.0001).
    2 context sentences
    Summary · context
    In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run-in).
    Summary · context
    Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161).

    In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.

  2. 08HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes on metformin plus liraglutide, Forty-three percent reached A1C below 7% with insulin detemir versus 17% without.

    In plain wordsIn adults with type 2 diabetes on metformin and liraglutide, more people reached the A1C target when insulin detemir was added.

    Peptide
    Liraglutide
    Outcome
    IncreaseProportion reaching A1C <7% with insulin detemir versus none (liraglutide background)
    Study

    n: not reported in source

    Comparator
    No insulin detemir
    Outcome group
    Glycemic control · Metabolic and weight

    Measurements

    Proportion with A1C <7%
    17%
    without insulin detemir

    Source sentences

    Summary
    Forty-three percent of participants with insulin detemir versus 17% without reached A1C <7%.
    2 context sentences
    Summary · context
    In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run-in).
    Summary · context
    Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161).

    In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.

  3. 09HumanNot a test of Liraglutide aloneRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes on metformin plus liraglutide, weight decreased by 0.16 kg with insulin detemir and by 0.95 kg without it.

    In plain wordsIn adults with type 2 diabetes on metformin and liraglutide, weight fell slightly in both groups, slightly less with insulin detemir.

    Peptide
    Liraglutide
    Outcome
    DecreaseWeight change in randomized phase (liraglutide background)
    Study

    n: not reported in source

    Comparator
    No insulin detemir
    Outcome group
    Body weight · Metabolic and weight

    Measurements

    Mean weight change
    −0.16 kg
    with insulin detemir
    Mean weight change
    −0.95 kg
    without insulin detemir

    Source sentences

    Summary
    then by 0.16 kg with insulin detemir or 0.95 kg without insulin detemir.
    2 context sentences
    Summary · context
    In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run-in).
    Summary · context
    Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161).

    In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.

  4. 10HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome

    In adults with type 2 diabetes on metformin plus liraglutide, no major hypoglycemia occurred in the randomized phase.

    In plain wordsIn adults with type 2 diabetes on metformin and liraglutide, no one had severe low blood sugar in the randomized phase.

    Peptide
    Liraglutide
    Outcome
    No significant changeMajor hypoglycemia in randomized phase (liraglutide background)
    Study

    n: not reported in source

    Comparator
    No insulin detemir
    Outcome group
    Adverse events · Metabolic and weight

    Source sentences

    Summary
    In the randomized phase, no major hypoglycemia occurred
    2 context sentences
    Summary · context
    In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run-in).
    Summary · context
    Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161).

    In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.

  5. 11HumanNot a test of Liraglutide aloneRandomized controlled trialSafety outcome

    In adults with type 2 diabetes on metformin plus liraglutide, minor hypoglycemia rates were 0.286 events per participant-year with insulin detemir and 0.029 without (9.2 vs. 1.3%).

    In plain wordsIn adults with type 2 diabetes on metformin and liraglutide, minor low blood sugar was more frequent when insulin detemir was added.

    Peptide
    Liraglutide
    Outcome
    IncreaseMinor hypoglycemia in randomized phase (liraglutide background)
    Study

    n: not reported in source

    Comparator
    No insulin detemir
    Outcome group
    Adverse events · Metabolic and weight

    Measurements

    Minor hypoglycemia rate
    0.286 events per participant-year
    with insulin detemir
    Minor hypoglycemia rate
    0.029 events per participant-year
    without insulin detemir

    Source sentences

    Summary
    minor hypoglycemia rates were 0.286 and 0.029 events per participant-year with and without insulin detemir (9.2 vs. 1.3%).
    2 context sentences
    Summary · context
    In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run-in).
    Summary · context
    Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161).

    In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00856986

The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 987Mar 2009 to Nov 2010

Diabetes · Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 8 Mar 2017

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    12 Oct 2026, 12:10 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:05 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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